http://scienceblogs.com/effectmeasu...ccine_story.php

O.K. so this is the report on the "crossover" protection of the current Vietnam 2004 vaccine that we have been waiting for.

It looks like the Vietnam 2004 (H5N1, clade 1) vaccine has been tested on Qinghai (H5N1, clade 2) and has been found to confer some significant immunity to the Qinghai strain (which was responsible for the Turkey outbreak in January). This is good news for the countries that are currently stockpiling and/or testing the Vietnam 2004 H5N1 vaccine.

Missing from this report is:

1. How much immunity does the Vietnam 2004, clade 1 vaccine provide against clade 2 Qinghai strains?

2. Does the Vietnam 2004 vaccine provide any immunity against the non-Qinghai, non-avian form of H5N1 of the current Indonesian H5N1 outbreak?

The Indonesian5 vaccine (taken from the first Indonesian H5N1 patient in 2005) is in testing. H5N1 has evolved in Indonesia since then. I hope Sanofi-Aventis and others, will be looking at how effective this vaccine is against the mammalian adapted strains of H5N1 currently circulating in Indonesia.

http://news.moneycentral.msn.com/pr...1020&ID=6121656
Single Injection of Vical's Avian Flu DNA Vaccine Provides 100% Protection in Ferrets

All PRNewswire NewsVIENNA, Austria, Oct. 20 /PRNewswire-FirstCall/ -- Vical Incorporated VICL today announced that a single injection of the company's lead avian influenza (flu) DNA vaccine candidate provided 100% protection in ferrets against lethal challenge with a highly virulent H5N1 virus (Vietnam/1203/2004). Conventional vaccines under development for avian flu typically have required two or more doses in humans, even with novel adjuvants, to produce the immunogenicity levels expected to provide protection.

The company had previously demonstrated that two doses of the vaccine candidate provided 100% protection in mice and ferrets against lethal challenges with H5N1 virus. A single-dose vaccine regimen could prove beneficial during a pandemic, both in extending vaccine supply to protect a greater number of people, and in achieving protective immune responses as quickly as possible. The studies were part of the company's program to develop a DNA vaccine to protect humans against emerging strains of flu virus that have the potential to cause a pandemic. Vical's three-component DNA vaccine candidate encodes two highly-conserved influenza virus proteins -- nucleoprotein (NP) and ion channel protein (M2) -- plus the H5 avian influenza virus surface protein, and is formulated with the company's patented Vaxfectin(TM) adjuvant.

"We are excited by the recent advances in our pandemic flu vaccine development program," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Earlier this week, we presented data from mouse studies demonstrating the dose-sparing ability of our Vaxfectin(TM) adjuvant when used with conventional flu vaccines. Today we presented data from ferret studies demonstrating the ability to provide complete protection with a single dose of our Vaxfectin(TM)-formulated avian flu DNA vaccine. Our goal is to advance into human testing with this program as quickly as possible, both to provide a potential defense against a pandemic outbreak and to explore the potential for a seasonal flu vaccine using a similar approach."

Larry R. Smith, Ph.D., the company's Vice President of Vaccine Research, presented the data Friday at the annual meeting of the Second International Conference on Influenza Vaccines for the World (Vienna, October 18 - 20). Financial support was provided under previously-announced grants from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). All lethal challenge testing was conducted in BSL-3 facilities at St. Jude Children's Research Hospital under the direction of Richard J. Webby, Ph.D.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether results in mouse and ferret studies will be predictive of results in human studies; whether Vical or others will continue development of the pandemic influenza DNA vaccine candidate; whether H5N1 or other strains of avian flu will emerge as pandemic threats; whether the company's DNA vaccine candidate will be effective in protecting humans against H5N1 or other strains of avian flu; whether development of an avian flu vaccine would lead to development of a seasonal flu vaccine; whether the flu vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the flu vaccine or any other product candidates; whether Vical or its collaborative partners will succeed in marketing the flu vaccine or any other product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

__________________ 
If you stand for nothing, you'll fall for anything. 

Another vaccine story

Posted on: October 19, 2006 7:32 AM, by revere

There's a report on the wires that scientists at the Vaccine Research Center (VRC) at U.S. National Institute of Allergy and Infectious Diseases have developed a DNA vaccine that protects mice against the reconstructed 1918 virus. The paper just appeared online in the Proceedings of the National Academy of Sciences (PNAS, also known as "penis" in the trade). At this point the paper is more important for what it reveals about how the mouse immune system protects against this notorious virus than as a demonstration of a vaccine technology for use in people. That is much further down the road.
The bottom line here is that the NIH and CDC team successfully immunized mice using a DNA vaccine. The idea behind a DNA vaccine is to insert DNA coding for an immunogenic viral protein into the host's own cells, inducing it to make the protein and thus stimulate an immune response. The PNAS paper shows that the DNA vaccine technique can protect mice from the lethal effects of the 1918 flu. It is not obvious that this technique will work in people. H5N1 vaccines that seemed to work fine in mice have sometimes not been very potent producers of immunity in human trials, so this is still pretty early days.

Using the genetic sequence information for the 1918 flu virus, Dr. [Gary] Nabel and his VRC colleagues created plasmids--small strands of DNA designed to express specific characteristics--carrying genes for the virus' hemagglutinin (HA) protein, the surface protein found in all flu viruses that allows the virus to stick to a cell and cause infection. The researchers created two types of plasmids: one to reflect the HA found in the original 1918 flu virus; the other an altered HA protein designed to attenuate (weaken) the virus.
Mice were then injected with a DNA vaccine containing both types of plasmids to determine whether they would generate immune responses to the 1918 virus. The researchers found significant responses both in terms of production of T-cells, the white blood cells critical in the immune system's battle against invading viruses, as well as the production of neutralizing antibodies.

To determine the vaccine's protective effects, the CDC's Dr. Tumpey intranasally exposed a group of mice to live, reconstructed 1918 virus 14 days after they were immunized with the experimental DNA vaccine. All 10 vaccinated mice survived the challenge with the deadly virus. To explore how the vaccine protected the animals, the researchers first depleted other mice of T-cells; however, this had no effect on the immunity of the vaccinated mice to the 1918 virus. In contrast, the researchers discovered that transferring antibody-rich immunoglobulin (IgG) from immunized mice to non-immunized mice resulted in antibody levels in the animals at levels only slightly lower than those that were immunized. Further, when the animals were exposed to the reconstructed 1918 flu virus, 8 of 10 mice that received antibodies from the immunized mice survived; none of the 10 mice that received IgG from the unvaccinated control group survived. (NIAID Press Release)


The DNA vaccine affected both the mouse cell-mediated immune system (the T-cells) and the humoral immune system (antibodies). Both are important in protecting against disease, and these mice survived challenge with the virus after vaccination. To see whether it was the T-cells or the antibodies, the research team also challenged vaccinated mice whose T-cells had been depleted and found they were still protected. Thus the working hypothesis was that the protection was from the antibodies produced in reaction to the protein, not the T-cells. To test this further, they took the fraction of mouse blood that contains antibodies (the immunoglobulin G, or IgG fraction) and injected it into unvaccinated mice and showed they, too, were protected, presumably from the antibodies generated by the vaccinated mice.

Thus this vaccine protects by raising antibodies to the virus -- in mice. As the authors point out, this does not mean cell mediated responses aren't important in humans. Moreoever, this mode of vaccination seems to work better in mice than humans, so at this point this paper is more important for its investigation of how the mouse immune system works against this virus.

There is already a company in the UK, PowderMed, that has been developing the DNA vaccine technique and it has just been bought by the world's largest drug maker, Pfizer (Bloomberg). It is relatively quick to prepare large amounts of specific DNA and no eggs are needed for this. thus this is one of several new vaccine techniques being developed. The PowderMed product uses needle-free administration by shooting the DNA into cells, coated onto gold particles, with a compressed gas injector. PowderMed is now conducting clinical trials.

There is another part of the paper related to preparing "pseudotyped viruses" that are safer to handle than the real thing. A lentivirus with the influenza HA protein coat was engineered and shown to be adequate for characterizing influenza virus antibody response. This would be very useful in allowing a better way to test for vaccine efficacy in neutralization tests (seeing whether the vaccine produces antibody that actually protects against infection), without the danger and cumbersome biosafety requirements of challenge with wild type virus.

So this is more vaccine news. Too bad we didn't do this kind of work several years ago. We might be there now and breathing easier. I'm not sure "better late than never" will be good enough if we have a pandemic.

http://scienceblogs.com/effectmeasu..._story.php#more

Report casts doubt on flu vaccine effectiveness

Updated Thu. Oct. 26 2006 7:49 PM ET

CTV.ca News Staff

With flu season upon us, a editorial in the British Medical Journal is warning that the flu shots many Canadians get every fall may not be as effective as we believe.


Across the world, health agencies recommend the use of inactivated flu vaccines, or vaccines containing dead flu viruses, to protect the population from seasonal outbreaks of influenza.


But because influenza viruses mutate from year to year, argues vaccine expert Tom Jefferson, it's difficult to study the precise effects of the widely-prescribed vaccines.


In fact, Jefferson says there's evidence proving these vaccines have little or no effect on things such as hospital stay, time off work, or even death resulting from influenza and its complications -- especially in elderly people.


Jefferson makes his arguments in a controversial report titled "Influenza vaccination: policy versus evidence," published in volume 333 of the British Medical Journal (BMJ).


The rationales behind the use of the vaccines in Canada and the U.S., he says, rests on the "heavy burden that influenza imposes on the population and the benefits of vaccination."

Canada backs present policy

Dr. Theresa Tam, an influenza expert with the Public Health Agency of Canada who has read Jefferson's report, said the agency stands behind its recommendation of flu vaccines.

"We base our policies or recommendations on scientific evidence, and we have reviewed all available evidence," Tam told CTV.ca on Thursday.

"Our summation is that the benefits of influenza vaccines outweigh any risk, and the vaccine is safe and effective. It can prevent hospitalization and save lives."


This is supported by the World Health Organization, which estimates that vaccinating elderly people reduces their risk of serious complications or of death by 70 to 85 per cent.


However, says Jefferson, WHO bases its recommendations on "single studies" that are random and are carried out from one or two seasons, making them "difficult to interpret."


"Single studies are also not reliable sources for generalizing and forecasting the effects of vaccines, especially when numbers are small," he said.


A better way, he said, would be to use systematic studies that average out over several years and test a large number of people in order to prove that these vaccines are having any effect.

The evidence

To highlight his claim that there's a lack of evidence backing the vaccine's effectiveness, Jefferson cites a study in the Cochrane review, "Vaccines for preventing influenza in healthy children," which found that in children under two years old, inactivated vaccines had the same effectiveness as placebo.


Further, a study in the same review for adults found that "in healthy people under 65 vaccination did not affect hospital stay, time off work, or death from influenza and its complication."


Jefferson says there is a "surprising" gap between what the policies of health agencies surrounding influenza tell us and the actual data.


"The reason for this situation are not clear and may be complex," says Jefferson.


He suggests there may be a confusion between influenza and influenza-like illness, where people are being diagnosed with the flu when they have something else.


"This confusion leads to a gross overestimation of the impact of influenza, unrealistic expectations of the performance of vaccines, and spurious certainty of our ability to predict viral circulation and impact."


He said this problem is compounded by the lack of accurate, fast surveillance systems that can tell exactly what viruses are going around in a community. Therefore, at the end of the flu season, there's no way for scientists to get an accurate picture of what went on to better prepare for future tends, said Jefferson.


In summary, Jefferson found in his research:

Public policy worldwide recommends the use of inactivated flu vaccines to prevent seasonal outbreaks.

Systematic reviews of large datasets from several decades provide the best information on how vaccines are performing since influenza viruses vary year to year -- but we're basing our policies today on poor, insufficient single studies.

There's little comparative evidence out there proving these vaccines are safe.

There's big gap between policy and evidence surrounding these vaccines. But there' are hug resources out there and health agencies urgently needed to re-evaluate their policies.

While Jefferson ignored several studies because of perceived weaknesses in their methodology, Dr. Tam said they nonetheless offer significant and useful data to health care specialists.


"When a program is in place, the other types of studies that are generated are ones that are more descriptive, where you don't have controls and cases. So methodologically, they may be considered weaker from that perspective," said Dr. Tam.

"However, they're nonetheless extremely useful and much more feasible to do. So we certainly believe there are a variety of studies out there. They may differ in the methodology, and some of them may have biases for which we will take into consideration when we're considering the strength of the study. But the bottom line is that the weight of evidence is such that we believe the influenza vaccine is effective."

http://www.ctv.ca/servlet/ArticleNe...?hub=TopStories

New Study Has Important Implications for Influenza Surveillance, Vaccine Formulation

Research Provides New Insights into Evolution of Flu Virus

Researchers are reporting results of a study that substantially alters the existing understanding of how the influenza virus evolves and that could have important implications for monitoring changes to the virus and predicting which strains should be used for flu vaccine. The study, which will be published in the online journal Biology Direct [http://www.biology-direct.com/] Oct. 26, 2006, was conducted by researchers from the National Library of Medicine’s National Center for Biotechnology Information (NCBI) [http://www.ncbi.nlm.nih.gov/] and Fogarty International Center [http://www.fic.nih.gov/], both part of the National Institutes of Health.

In an effort to better understand how seasonal influenza evolves into new strains, the researchers analyzed the genomic sequences of a large and representative collection of the two most common flu strains (called H3N2 and H1N1) from the 1995-2005 flu seasons in New York state and New Zealand. The sequence data was obtained from the Influenza Genome Sequencing Project [http://www.ncbi.nlm.nih.gov/genomes/FLU/FLU.html], which recently generated over 1,000 fully sequenced influenza genomes from clinical isolates; the project is funded and managed by the National Institute of Allergy and Infectious Diseases [http://www3.niaid.nih.gov/].

The analysis revealed a picture of flu evolution that was surprisingly different from the prevailing conception of how the virus changes. Evolution of influenza A virus is commonly viewed as a typical Darwinian process. In this mode of evolution, the virus’ main surface protein, hemagglutinin (HA), is thought to continually change to evade human immune response, resulting in new dominant strains that eliminate all competitors in a series of rapid successions. Unexpectedly, however, the study found that the periods of intense Darwinian selection accounted for only a relatively small portion of H3N2 flu evolution during the ten-year period examined.

The study found that much of the time the H3N2 virus seemed to be “in stasis”; that is, the HA gene showed no significant excess of mutations in the antigenic regions (those recognized by the immune system).

During these stasis periods, none of the co-circulating strains is significantly more fit than others, apparently because multiple mutations are required to substantially improve the virus’ ability to evade the immune system.

As a result, an increased variety of strains accumulates. Ultimately, however, one of the variants will come within one mutation of achieving higher fitness and becoming dominant. Once the crucial last mutation does occur, virus evolution shifts from stasis to a brief interval of rapid Darwinian evolution, where the new dominant virus rapidly sweeps through the human population and eliminates most other variants.

Based on their results, the researchers conclude that “the common view of the evolution of influenza virus as a rapid, positive selection-driven process is, at best, incomplete.” Because the periods of stasis allow the proliferation of many small groups of related viruses, any of which could become the next dominant virus strain, the authors suggest that sequencing much larger numbers of representative isolates could be helpful in augmenting current surveillance methods.

The study, titled “Long Intervals of Stasis Punctuated by Bursts of Positive Selection in the Seasonal Evolution of Influenza A Virus,” is authored by Yuri Wolf, PhD, NCBI; Cecile Viboud, PhD, Fogarty International Center; Edward Holmes, PhD, Fogarty International Center and Pennsylvania State University; Eugene Koonin, PhD, NCBI; and David Lipman, MD, NCBI.

Established in 1988 as a national resource for molecular biology information, NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing molecular and genomic data, and disseminates biomedical information – all for the better understanding of processes affecting human health and disease. NCBI is a division of the National Library of Medicine [http://www.nlm.nih.gov/] at the National Institutes of Health (NIH).

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

http://www.nih.gov/news/pr/oct2006/nlm-25.htm

Amassing armies of co-existing candidates in 'silent' mode, waiting for the inevitable one strain that will hit the bull's eye. That would more or less cover what we're witnessing now.

Good find!

You've got to wonder...

Let's say, just for the sake of argument, that this year's vaccine has strains X, Y, and Z. Enough people are vaccinated that the chain of infections breaks, and so few people get X, Y, or Z. Doesn't that leave the door open for strains Q, P, and R? It doesn't invalidate the usefulness of the vaccine to keep people from getting X, Y, and Z. But the number of flu infections doesn't go down, since Q, P, and R are still circulating.

__________________ 
 

There is the occasional mismatch concerning the 'most dominant' strain, and it does have nasty consequences sometimes, but it's still 'seasonal' flu.

What worries me is that H5N1 is on the same track: masses of strains co-circulating, and a couple of them 'closing in' on mammals. If the above applies equally for H5N1 - and why wouldn't it? - the outcome seems fairly predictable.

New Study Has Important Implications for Influenza Surveillance, Vaccine Formulation
Research Provides New Insights into Evolution of Flu Virus
http://www.nih.gov/news/pr/oct2006/nlm-25.htm
Researchers are reporting results of a study that substantially alters the existing understanding of how the influenza virus evolves and that could have important implications for monitoring changes to the virus and predicting which strains should be used for flu vaccine. The study, which will be published in the online journal Biology Direct [http://www.biology-direct.com/] Oct. 26, 2006, was conducted by researchers from the National Library of Medicine’s National Center for Biotechnology Information (NCBI) [http://www.ncbi.nlm.nih.gov/] and Fogarty International Center [http://www.fic.nih.gov/], both part of the National Institutes of Health.

In an effort to better understand how seasonal influenza evolves into new strains, the researchers analyzed the genomic sequences of a large and representative collection of the two most common flu strains (called H3N2 and H1N1) from the 1995-2005 flu seasons in New York state and New Zealand. The sequence data was obtained from the Influenza Genome Sequencing Project [http://www.ncbi.nlm.nih.gov/genomes/FLU/FLU.html], which recently generated over 1,000 fully sequenced influenza genomes from clinical isolates; the project is funded and managed by the National Institute of Allergy and Infectious Diseases [http://www3.niaid.nih.gov/].

The analysis revealed a picture of flu evolution that was surprisingly different from the prevailing conception of how the virus changes. Evolution of influenza A virus is commonly viewed as a typical Darwinian process. In this mode of evolution, the virus’ main surface protein, hemagglutinin (HA), is thought to continually change to evade human immune response, resulting in new dominant strains that eliminate all competitors in a series of rapid successions. Unexpectedly, however, the study found that the periods of intense Darwinian selection accounted for only a relatively small portion of H3N2 flu evolution during the ten-year period examined.

The study found that much of the time the H3N2 virus seemed to be “in stasis”; that is, the HA gene showed no significant excess of mutations in the antigenic regions (those recognized by the immune system). During these stasis periods, none of the co-circulating strains is significantly more fit than others, apparently because multiple mutations are required to substantially improve the virus’ ability to evade the immune system. As a result, an increased variety of strains accumulates. Ultimately, however, one of the variants will come within one mutation of achieving higher fitness and becoming dominant. Once the crucial last mutation does occur, virus evolution shifts from stasis to a brief interval of rapid Darwinian evolution, where the new dominant virus rapidly sweeps through the human population and eliminates most other variants.

Based on their results, the researchers conclude that “the common view of the evolution of influenza virus as a rapid, positive selection-driven process is, at best, incomplete.” Because the periods of stasis allow the proliferation of many small groups of related viruses, any of which could become the next dominant virus strain, the authors suggest that sequencing much larger numbers of representative isolates could be helpful in augmenting current surveillance methods.

The study, titled “Long Intervals of Stasis Punctuated by Bursts of Positive Selection in the Seasonal Evolution of Influenza A Virus,” is authored by Yuri Wolf, PhD, NCBI; Cecile Viboud, PhD, Fogarty International Center; Edward Holmes, PhD, Fogarty International Center and Pennsylvania State University; Eugene Koonin, PhD, NCBI; and David Lipman, MD, NCBI.

Established in 1988 as a national resource for molecular biology information, NCBI creates public databases, conducts research in computational biology, develops software tools for analyzing molecular and genomic data, and disseminates biomedical information – all for the better understanding of processes affecting human health and disease. NCBI is a division of the National Library of Medicine [http://www.nlm.nih.gov/] at the National Institutes of Health (NIH).

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.









Here is the link to the pdf

http://www.biology-direct.com/conte...5-6150-1-34.pdf

__________________ 

"When someone loves you, the way they say your name is different. You just know that your name is safe in their mouth."
Billy - age 4

stephanie

 

Try post #86

31 October 2006

Vaccine death: maker quizzed

The Procurator Fiscal’s office in Dundee, investigating the death of a woman following her devastating reaction to a flu jab, is seeking answers from the German pharmaceuticals company that made the vaccine (writes Bruce Robbins).

Depute fiscal Kirsty McGowan said the firm has been asked if it is aware of any other adverse reactions to the vaccine.
Dundee woman Sylvia Thomson suffered a fatal reaction to the injection in November last year and died a few weeks later, on December 2,.

The former PE teacher, who’d been bothered by an intermittent chest infection, asked her GP for the jab as a precaution. A week later, she was taken into hospital suffering from encephalitis — swelling in her brain.

Hospital officials have since admitted that other people may be predisposed to a similar reaction.

Mrs Thomson’s husband, Robert, has been pushing for a fatal inquiry into his 56-year-old wife’s death and is critical of the progress the fiscal’s department has made into the investigation.

However, Ms McGowan told the Evening Telegraph she would be taking the matter further if she didn’t hear back from the company in two to three weeks.

She added, “We have received a fax from one of the vaccine companies saying they have referred our inquiry back to the parent company in Germany. Solvay Pharm-aceuticals is German-owned and has a base in Holland. They have to provide us with a full answer and that couldn’t be done by the distributors in Britain.

“We’ve identified the batch numbers of the vaccine concerned and are waiting for a report from the company. We are looking for other adverse reactions to the vaccine and the company will have all those details.”

Ms McGowan rejected Mr Thomson’s claims the matter hadn’t been given a high enough priority and said she had updated him at the beginning of October.”

Mr Thomson said he believed the fiscal’s department had spent a lot of time speaking to Mrs Thomson’s GP and a doctor at Ninewells Hospital when they should have been on to the drugs company straight away.

“There must be a Government body that approved the vaccine for use in the UK and the fiscal could have contacted them straight away to find out what tests had been carried out on it before it was made available.

“There was a report out recently saying that it couldn’t be proved that ‘flu vaccines do any good. Here we are heading into the vaccination season and we still don’t know if this particular vaccine is going to stop people getting the ‘flu or end up killing others.”

http://www.eveningtelegraph.co.uk/o...y8917245t0.shtm

So, what do you people think? I have never had the flu ever in my life, and I've never taken any vaccine. But I was thinking about getting a shot this year, but after reading this I'm having some doubts. Is it worth it? I've never caught the flu before, and I doubt I'll catch it this year either. Only reason I'd take the shot is if there's a pandemic, to stop any cross-infection from happening. But if the dead virus vaccines don't really give any immunity.. why do it? We don't have flu mist in Sweden, so it's this or nothing.

Generex Biotechnology to Begin the First Human Clinical Trial of Avian Influenza Vaccine

Company signs agreement with the Lebanese-Canadian Hospital in Beirut as a site for trials

TORONTO, Nov. 6, 2006 - Generex Biotechnology Corporation (NasdaqCM:GNBT) announced today that it has entered into an agreement with the Lebanese-Canadian Hospital in Beirut, Lebanon to conduct a human clinical trial of the Antigen Express synthetic avian influenza vaccine, representing the first studies to be conducted in man.

The study is being undertaken with the approval of the appropriate Lebanese governmental and regulatory bodies. Antigen Express, Inc., a wholly-owned subsidiary of Generex, designed the vaccine using its proprietary platform technology and has been conducting pre-clinical studies since 2004. Dr. Alexander Abdelnoor, Department of Microbiology & Immunology, Faculty of Medicine, American University of Beirut, will also be participating as a consultant for the trials.


The vaccine being developed by Antigen Express is based upon simple peptide-synthesis technology and can thus be manufactured rapidly, easily, and at inexpensive cost. This is in sharp contrast to traditional egg-based vaccines that rely on biological systems for vaccine production, making their availability to at-risk populations during a pandemic extremely limited. The preclinical studies conducted with the synthetic vaccine suggest that it may be used with more traditional vaccines to extend their utility as well as to prevent mortality associated with H5N1 infection when used alone.


The Antigen Express vaccine consists of specific fragments of the H5 protein from the H5N1 influenza virus that have been modified to enhance their potency in stimulating CD4+ T helper cells. Flu specific T helper cells have been shown to be essential in the development of a robust, protective immune response against influenza.

The methods for enhancing the immune stimulating potency of the fragments were developed by Dr. Robert Humphreys, founder of Antigen Express. In brief, specific fragments of the H5 protein are identified (antigenic epitopes) that have the potential to interact with MHC class II molecules. The ability of CD4+ T helper cells to become stimulated to recognize specific proteins depends upon the presentation of epitopes derived from that protein to CD4+ cells by MHC class II molecules. Based upon an understanding of MHC class II charging by antigenic epitopes, Antigen Express scientists have developed proprietary methods for increasing the vaccine potency of antigenic peptides.


A similar synthetic peptide vaccine designed by the same methods targeting a tumor-associated protein (encoded by HER-2/neu) has been in the clinic for more than a year at the Walter Reed Army Medical Center (WRAMC). That compound has shown good activity in the antigen-specific stimulation of CD4+ T helper cells.


"The trials in Lebanon will complement nicely the studies planned for the US," said Dr. Eric von Hofe, President of Antigen Express. "We know that bird flu is a threat that shows no signs of going away soon. Coupled with the lack of any widely available vaccine, it is paramount to begin testing the synthetic vaccine being developed at Antigen Express as rapidly as possible."

http://www.pharmalive.com/News/inde...9&categoryid=21

Skin Patches Instead of Shots?
The Associated Press
By LAURAN NEERGAARD
November 06, 2006
http://www.topix.net/content/ap/368...469783333029430

There definitely is promise to that idea

Dreaded vaccinations one day could be as simple as sticking on a Band-Aid _ ouchless and do-it-yourself.

Early tests of skin-patch vaccines are beginning in hundreds of volunteers, one version designed to protect against the flu and another to prevent travelers' diarrhea.

The idea isn't just pain-free vaccination. The National Institutes of Health is helping fund patch research in hopes of strengthening today's imperfect flu shots, and gaining extra help if bird flu or some other super-flu ever triggers a pandemic.

Indeed, patch developer Iomai Corp. proposes that the mailman, not a doctor, deliver flu vaccine during a pandemic. Once a vaccine is brewed, simply ship patches to people's homes with instructions to slap one on.

Doctors might not like the go-it-alone method. But the technology's main promise may be in developing countries. Unlike syringe-based vaccines, patches wouldn't need refrigeration _ nor pose the infection risk of reused needles, a continuing problem.

Only time will tell if the patches really work. Iomai is in initial stages of human testing, and years of additional work are required for proof. But previous research does suggest the skin could provide an improved route to rev up the immune system, perhaps allowing doctors to use lower vaccine doses.

'It may be that the expectations for vaccine patch technology are now slowly bearing fruit,' says Dr. William Schaffner of Vanderbilt University, a vaccine expert who has long monitored the field.

'It is what I would call an alluring technology.'

If it works against one disease, a patch likely could be tweaked to deliver numerous kinds of vaccines. Iomai also has Defense Department funding to help develop an anthrax vaccine patch.

'The approach is novel and may be the way many vaccines are given in the future,' says Dr. Herbert DuPont of the University of Texas Health Sciences Center in Houston. A specialist in diarrheal diseases, he is helping Iomai test the travelers' diarrhea patch in U.S. tourists headed for Mexico.

Most of today's vaccines are shots into muscle. But doctors have long known that getting vaccine just inside the skin is deep enough. History's first crude inoculations, against smallpox, merely involved scratching pus from a related but milder virus into the skin. And recent research using small needles to push flu vaccine just inside the skin found lower doses could be as protective as full-strength muscle shots.

The question is how to do skin vaccination without actually breaking the skin. Patches frequently deliver medications, such as nicotine or birth control. But drugs are very small molecules that can fairly easily penetrate skin to reach the bloodstream. Vaccines typically contain much larger proteins.

Iomai's method, discovered by one of its founders at the Walter Reed Army Institute of Research: Just get past a thin outer layer of dead skin to the epidermis, the first living skin layer. There, specialized cells called Langerhans cells can recognize a pathogen and speed to the lymph nodes to alert the immune system.

In Iomai's laboratory in Gaithersburg, Md., outside Washington, CEO Stanley Erck demonstrates: He brushes his skin with a gadget bearing a bit of sandpaper, like the kind used for filing fingernails. The round patch then is stuck to the scuffed spot for several hours.

'We're not inventing anything new, just exposing pathogens the way humans have seen them all their life,' Erck says.

Now come the tests:

_Furthest along are patches designed to protect against an E. coli strain called ETEC, a leading cause of travelers' diarrhea. DuPont's study aims for up to 300 participants to spend at least two weeks in Mexico or Guatemala, visiting pre-specified clinic sites there if they do get diarrhea to see if the patch failed or if the culprit was some other germ.

In an initial challenge study at Johns Hopkins University last year, patch recipients who drank the bacteria suffered significantly less diarrhea than their unvaccinated counterparts, Erck said.

_Last month, Iomai began first-stage testing of flu vaccine patches in 270 volunteers, to track the patches' safety and whether recipients develop as many flu-fighting antibodies as those given standard flu shots.

_Another goal is immune-stimulating patches to boost a vaccine's effects. The elderly are less protected by today's flu shots than young people. And studies of bird-flu vaccine show that a huge dose will be required regardless of age, unless immune-boosters can help stretch supplies.

Iomai's travelers' diarrhea patch also seems to give the immune system a general boost. In a small study last year, giving elderly volunteers that patch plus a standard flu shot spurred a greater immune response than the shot alone. The company now is preparing a larger study, and competing for a government contract to add immune-boosting patches to a federal stockpile of flu pandemic supplies.

'There definitely is promise to that idea,' says Dr. David S. Cho of the NIH's flu product development office, who monitors the patch project _ although he cautions that Iomai must prove if the immune booster works with a variety of flu strains.

Lauran Neergaard covers health and medical issues for The Associated Press in Washington.


Kris (MomCares)

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

Link?

Oooops...

http://www.topix.net/content/ap/368...469783333029430

Kris (MomCares)

p.s. I'll also add it to the OP.

__________________ 

"I don't want to make money. I just want to be wonderful." - Marilyn Monroe

Don't anthropomorphize viruses. They hate that.

 

This GSK article is posted here from another Thread for safe keeping.

See Post 37, on page one, for the related Helen Branswell article regarding Canadian hard nosed negotiations with GSK ("It is expected countries with vaccine plants within their borders may even block exports until domestic needs have been met, regardless of whose order was placed first."), etc., etc.

New vaccine being tested offers protection against most avian flu strains

Posted: 22 November 2006 1820 hrs


SINGAPORE : A new vaccine that promises protection against a wide range of avian influenza virus has been developed.

The vaccine which is produced using a cell-based technology is still in its early phase of clinical trials.

The bird flu virus has been detected in many countries - mostly in Asia such as Indonesia, Vietnam and Thailand with different strains reported.

Now preliminary findings of clinical trials of the vaccine developed by pharmaceutical company Baxter show that it can induce antibodies that neutralise widely divergent strains of the H5N1 virus.

Dr Noel Barret, Vice President - Global R&D Vaccines, Baxter AG, said: "It reacts not only with the strains from which the vaccine is made but it also reacts with highly divergent H5N1 strains so the expectations is that such a vaccine could protect against strains which will be emerging in maybe 6 months', 12 months' time and 2 years' time."

The vaccine was produced using a cell-based technology which takes about 11 weeks to produce.

Today most influenza vaccine is produced using the egg-based method where the virus is introduced into the embryos and takes up to 28 weeks to produce.

This method has been used for nearly 50 years.

Baxter says some benefits using the cell-based system for the production of influenza vaccines include doing away with constraints of depending on the supply of eggs which can pose a challenge if a pandemic affects the supply of chickens.

Dr Barret says that the vaccine seems to work well even at the lowest dose level.

The company's study on mice found that 100 percent of mice immunised with the vaccine survived the Vietnam strain, the Hong Kong strain and the Indonesian strain of the H5N1.

The trial on humans shows that more than 75 percent of those injected with the vaccine were able to produce the antibodies.

Dr Barret said: "You cannot talk about efficacy because efficacy means protection against infection. We can't measure that in with H5N1 to date. What we can do is that we can determine the amount of subjects that produce what we anticipate are protective antibodies."

The clinical trial involved 270 healthy adults from Singapore and Austria and was carried out between June and September this year.

Baxter says that Singapore was chosen as a centre for its excellent infrastructure and facilities for conducting research.

Some 115 patients were recruited from Changi General Hospital and the National University Hospital, while the rest were from Austria.

The company says that the side effects from the vaccine are minor, such as fatigue, headaches and a slight fever.

Baxter plans to conduct a larger study involving at least 600 patients.

Among other things, it hopes to determine the optimal dosage in humans for the vaccine to be effective.

There is currently no vaccine against the bird flu on the market. - CNA/ch

http://www.channelnewsasia.com/stor.../242905/1/.html

Nippon Rinsho. 2006 Oct ;64:1855-64 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
[Development of attenuated H5N1 avian influenza vaccines using reverse genetic technology]
Takato Odagiri
Outbreaks caused by highly pathogenic H5N1 avian influenza viruses have spread worldwide and the containment is impossible no longer. During the outbreaks, over 200 human infection cases with 55% fatality are confirmed at the moment and some human-to -human transmission in family clusters have been observed in Vietnam, Thailand and Indonesia. The potency of pandemic caused by highly pathogenic H5N1 avian influenza is increasing gradually. Consequently, development of effective H5N1 vaccine and its licensing for vaccination to human are urgent countermeasures for pandemic preparedness. In the present article, the author reviews the development of H5N1 attenuated vaccine by reverse genetic technology and discuss the problems on the vaccine production to be dissolved before pandemic occur.


Latest similar papers:


Emerg Med Australas. 2006 Oct ;18(5-6):420-9 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Avian influenza: A pandemic waiting in the wings?
Alan W Hampson
Recent widespread outbreaks of avian influenza and, associated with these a growing number of human infections with a high mortality rate, have raised concerns that this might be the prelude to a severe pandemic of human influenza. As a background to these concerns the present article reviews influenza as a human disease, its origins and the involvement of other species, properties of the influenza viruses and the current status of influenza prevention and control.


Nurs Stand. ;21:51-6; quiz 58 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Avian influenza: are you prepared?
S Campbell
This article aims to assist healthcare workers to prepare, both in their professional and personal life, for a possible influenza pandemic. It identifies the medical and non-medical interventions that may be required.


Uirusu. 2006 Jun ;56:77-84 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Preparedness and international contribution on H5N1 highly pathogenic avian influenza and pandemic-influenza.
Takato Odagiri
Since the end of 2003, simultaneous outbreaks caused by H5N1 highly pathogenic avian influenza viruses (H5N1-HPAIV) occurred in poultries and in wild birds in the East Asia. The outbreaks are spreading now at least 48 countries in the Middle Eastern, African and European countries in addition to the East Asia. During the outbreaks, over 200 human infection cases with 55% fatality are confirmed at the moment and some human-to-human transmission in family clusters have been observed. The outbreaks are no more out of control and pandemic potential caused by H5N1-HPAIV is major concern. Therefore, it is urgently necessary to develop new diagnostic kits and effective vaccines and to stockpile anti-influenza drugs before pandemic alert period phase 4 defined by WHO. Furthermore, international supports to the affected countries for development and improvement of diagnostic system are required in the public health aspect.


Health Res Policy Syst. 2006 Oct 13;4:8 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Global response to pandemic flu: more research needed on a critical front.
Meng-Kin Lim
ABSTRACT: If and when sustained human-to-human transmission of H5N1 becomes a reality, the world will no longer be dealing with sporadic avian flu borne along migratory flight paths of birds, but aviation flu - winged at subsonic speed along commercial air conduits to every corner of planet Earth. Given that air transportation is the one feature that most differentiates present day transmission scenarios from those in 1918, our present inability to prevent spread of influenza by international air travel, as reckoned by the World Health Organization, constitutes a major weakness in the current global preparedness plan against pandemic flu. Despite the lessons of SARS, it is surprising that aviation-related health policy options have not been more rigorously evaluated, or scientific research aimed at strengthening public health measures on the air transportation front, more energetically pursued.


Nippon Rinsho. 2006 Oct ;64:1855-64 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
[Development of attenuated H5N1 avian influenza vaccines using reverse genetic technology]
Takato Odagiri
Outbreaks caused by highly pathogenic H5N1 avian influenza viruses have spread worldwide and the containment is impossible no longer. During the outbreaks, over 200 human infection cases with 55% fatality are confirmed at the moment and some human-to -human transmission in family clusters have been observed in Vietnam, Thailand and Indonesia. The potency of pandemic caused by highly pathogenic H5N1 avian influenza is increasing gradually. Consequently, development of effective H5N1 vaccine and its licensing for vaccination to human are urgent countermeasures for pandemic preparedness. In the present article, the author reviews the development of H5N1 attenuated vaccine by reverse genetic technology and discuss the problems on the vaccine production to be dissolved before pandemic occur.


Nippon Rinsho. 2006 Oct ;64:1781-8 [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
[Pandemic influenza measures in Japan--from the point of government]
Yasuhiro Nishijima, Masaru Umeda
H5N1 type avian flu infection has spread among poultry starting from Vietnam to southwest region countries since the end of 2003. Afterwards, the infections have expanded through Africa, Europe and even to worldwide. Cases of H5N1 type avian flu virus infections to human are increasing. So, the risk of acquiring, through mutation, capacity of human-to-human spread would be higher. As human has not been infected by such virus, it is worried that a pandemic, and even the increase of deaths due to this virus could be occurred. Japan produced "Pandemic Influenza Preparedness Action Plan" last year, and also takes genuine measures against a new pathogenic avian influenza virus. Various countries, including Japan, are trying to find positive measures towards it, although it has not been found.


Vaccine. 2006 Jun 5;: [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Cross-protective immunity in mice induced by live-attenuated or inactivated vaccines against highly pathogenic influenza A (H5N1) viruses.
Xiuhua Lu, Lindsay E Edwards, Julia A Desheva, Doan C Nguyen, Andrey Rekstin, Iain Stephenson, Kristy Szretter, Nancy J Cox, Larisa G Rudenko, Alexander Klimov, Jacqueline M Katz
Because of the time required to identify and produce an antigenically well-matched pandemic vaccine, vaccines that offer broader cross-reactive immunity and protection are desirable. We have compared a live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) based on a related H5 hemagglutinin (HA) from a nonpathogenic avian influenza virus, A/Duck/Pottsdam/1042-6/86 (H5N2), for the ability to induce cross-reactive immunity and/or cross-protective efficacy against a contemporary highly pathogenic H5N1 viruses. Both LAIV and IIV provided cross-protection from systemic infection, severe disease, and death following lethal challenges with antigenically distinct A/Vietnam/1203/2004 (VN/1203) virus. Substantial levels of serum anti-VN/1203 HA IgG were detected in mice that received either IIV or LAIV, while nasal wash anti-VN/1203 HA IgA was detected in mice that received LAIV. Formulation of IIV with alum adjuvant augmented neutralizing antibody responses and protective efficacy. These results demonstrated that vaccination of mice with H5 IIV or LAIV induced a high degree of cross-protection from illness and death following lethal challenges with a heterologous H5N1 virus.


Virology. 2006 Oct 6;: [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Efficacy of inactivated vaccines against H5N1 avian influenza infection in ducks.
Deborah Middleton, John Bingham, Paul Selleck, Sue Lowther, Laurie Gleeson, Philip Lehrbach, Simon Robinson, Jeff Rodenberg, Mahesh Kumar, Marion Andrew
The current Asian H5N1 highly pathogenic avian influenza virus has spread over much of Asia and into Europe and Africa. As well as affecting village and commercial chicken operations in many South East Asian countries, it differs from past H5 avian influenza viruses in that it causes morbidity and mortalities in other domesticated birds, such as ducks and turkeys and in wild waterbirds. Effective vaccines that can prevent infection, as well as disease, and be used in a variety of avian species are needed for field use. In this report, a bivalent H5N9+H7N1 oil emulsion vaccine is compared, in ducks, to a monovalent H5N3 oil emulsion vaccine that has been derived by reverse genetics with an H5 from A/chicken/Vietnam/C58/04. While both vaccines protected against morbidity, the monovalent vaccine provided effective protection, with no evidence of shedding of the challenge virus and no serological response to the H5N1 challenge virus.


Hum Vaccin. 2006 Jan 29;2: [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Vaccine Development for an Imminent Pandemic: Why We Should Worry, What We Must Do.
David Fedson
The avian H5N1 virus continues to evolve and poses an imminent pandemic threat. Pandemic vaccine development, however, has progressed slowly. For it to succeed, it must be based on a public health perspective that reflects the arithmetic of pandemic vaccine demand, especially by countries without vaccine companies. Clinical trials of H5N1 vaccines have been discouraging, and we must understand why the H5N1 virus is so poorly immunogenic. Antigen-sparing pandemic vaccines will be required, and future trials must identify the most effective adjuvant and determine whether whole virus vaccines will be needed. Problems related to intellectual property and concerns about several regulatory issues must be resolved. Public funding for clinical trials must be provided and firm leadership and coordination exercised by national and international (WHO) public health officials. Vaccination for an imminent pandemic requires a global perspective not only for vaccine development but also for vaccine production and distribution.


Trends Mol Med. 2006 Sep 28;: [Pubmed] [Scholar] [Select] [Drop] [Hide] [Show]
Strategies for developing vaccines against H5N1 influenza A viruses.
Taisuke Horimoto, Yoshihiro Kawaoka
Recent outbreaks of highly pathogenic avian influenza A virus (H5N1 subtype) infections in poultry and humans (through direct contact with infected birds) have raised concerns that a new influenza pandemic might occur in the near future. Effective vaccines against H5N1 virus are, therefore, urgently needed. Reverse-genetics-based inactivated vaccines have been prepared according to World Health Organization (WHO) recommendations and are now undergoing clinical evaluation in several countries. Here, we review the current strategies for the development of H5N1 influenza vaccines, and future directions for vaccine development.

It would be usefull to hear for some report from this... when done of course

http://www.who.int/mediacentre/even...2/en/index.html

Vaccine news from another Thread today:

The vaccine development news gets better all the time.

Adjuvantcated vaccines with small doses and strong immune responses; cell based technology to free vaccines from reliance on fragile chicken eggs in short supply; more and better vaccine production facilities; and eventually, enough pre-Pandemic H5N1 vaccine to make it publicly available for sale along with the annual 3-way flu vaccine.

The tons of money poured into Pandemic vaccine R & D by the "worse case scenario" folks at the NIH and DOD in the past 18 months is beginning to bear fruit.

If a Pandemic holds off for another two to three years, the developed world at least, may dodge the worse of a Pandemic bullet. Otherwise, the U.S. with a large 300 million population will be in big trouble. Nations with smaller populations to protect and/or vaccine production plants in their borders, will be able to make/obtain pre-Pandemic and Pandemic vaccines much quicker and easier than the U.S.

Canada, the European Union Nations, Australia, New Zealand, etc., all will be better off. Witness that Switzerland has ordered enough pre-Pandemic H5N1 vaccine (probably clade one) for all of it's 7.5 million population. The 20 million doses ordered by the U.S., is a drop in the bucket for it's 300 million strong population.

The more time we have to prepare for a Worse Case Pandemic Scenario, the better.

The Novartis/Chiron vaccine seems promising indeed.

May be a drawback: the vaccin is based on MDCK cell culture:

http://www.novartis-vaccines.com/pi...u_culture.shtml

I found an evaluation of the FDA advisory commitee regarding different cell cultures, stating that MDCK cell culture from Chiron (Novartis) has a high tumorgenicity.


See attachment.

Other attachment shows a timeline of several vaccins which are developed at the moment, including the Novartis/Chiron vaccin.


Disclaimer: poster has some Crucell shares....., make your own judgement!

Attached Images

  

11/29/06
Contact: Charles Martin, (334) 844-9986 (marticd@auburn.edu), or
Mike Clardy, (334) 844-9999 (clardch@auburn.edu)

AU PROFESSOR DEVELOPS FIRST EGG-INJECTED POULTRY VACCINATION AGAINST AVIAN INFLUENZA

AUBURN - An Auburn University veterinary professor in collaboration with researchers at Vaxin Inc. of Birmingham has developed the first “in ovo,” or egg-injected, vaccine to protect chickens against avian influenza, a virus threatening human health and global poultry populations.

Haroldo Toro, whose research is in press in the scientific journal, Vaccine, says it would provide 100 percent protection once an outbreak’s strain is determined.

“We have proven the principle, which is the major step in leading to commercially produced vaccine that could be vital to the poultry industry,” Toro said. “When an outbreak occurs, we would determine the strain and quickly create a vaccine within three months specifically for it.”

The researchers inserted a gene from a low pathogenic avian flu virus strain (H5N9) into a non-replicating human virus, a Vaxin proprietary technology, which was then injected into developing chicken embryos still in the egg. When protection induced by the vaccine was tested against two highly pathogenic avian flu viruses, a Vietnam H5N1 strain and a Mexican H5N2 strain, the results showed 68 percent and 100 percent protection, respectively.

“These strains have slightly different genetic makeups which account for the different percentages in protection,” said Toro, who is also collaborating on this project with the Southeast Poultry Research Laboratory in Athens, Ga. “Our results indicate that we can provide effective protection against any strain after incorporating the gene of the field strain into our vaccine construct.”

The disease has decimated poultry populations in Asia in recent years. Toro says United States health officials are continuously monitoring both chicken flocks and migratory birds that might bring new, highly pathogenic strains of the disease and infect poultry flocks, possibly killing between 90 to 100 percent in affected areas.

The current policy of health officials during an outbreak of highly pathogenic avian flu is mass euthanasia and disposal of infected birds, and strict biosecurity measures. Mass vaccination programs around the perimeter region would help to reduce the risk of further dissemination of the field virus to neighboring areas. Because this new vaccine also allows easy differentiation between naturally infected birds and vaccinated birds, it could also be used to prevent outbreaks of disease in case of immediate risk from a known strain affecting, for example, neighboring countries.

“We can vaccinate lots of birds in a quick, cost- and labor-saving manner which otherwise would not be possible,” Toro said. “Most poultry operations already have automated injection machines to vaccinate against Marek’s disease, injecting up to 40,000 eggs per minute. Our vaccine is produced through cell cultures, so we can easily make enough vaccine for thousands of birds.”

He says this procedure is much easier than producing inactivated, or killed, vaccines, which require replicating the live avian influenza virus in egg embryos and individual delivery by injection. In addition, naturally infected chickens cannot be differentiated from those vaccinated if the strain used for vaccination is the same as the one acting in the field. Currently available recombinant vaccines, using fowlpox vectors, are injected into the chicken and have been shown to be less effective in birds pre-exposed to the fowlpox vector. Pre-exposure to the vector used in this novel vaccine is extremely unlikely in chicken populations.

“Both of the current methods are difficult and labor intensive, and are too time consuming, when time is critical,” he said. “The in-egg vaccine is easy to produce, easy to administer and very effective.”

He adds, “The vaccine would, in turn, reduce the risk for human exposure to avian influenza.” Even though the risk to people is low, there have been confirmed cases among humans reported since 1997, primarily in Asia as a result of contact with infected chicken, ducks and turkeys.

Toro’s research is funded through a USDA program set up in 2004 for universities to study avian influenza. The next step is gaining federal approval to commercially produce the vaccine.

“We are looking at two or three years for federal approval, but it might be much sooner if an outbreak occurs,” he said. “We have a very good tool against avian flu. No one has done this before.”

Auburn University is a preeminent land-grant and comprehensive research institution with more than 23,000 students and 6,500 faculty and staff. Ranked among the top 50 public universities nationally, Auburn offers more than 230 undergraduate, graduate and doctoral degree programs.

(Contributed by Charles Martin. Photos available on request.)

###

nov06:AU-avianfluresearch

http://www.ocm.auburn.edu/news_rele...luresearch.html


This article is dated yesterday...I did a scan through this thread and didn't see it, so I hope this is not a dup. and is in the right thread.

__________________ 
The Lord is my light and my salvation; Whom shall I fear?
The Lord is the strength of my life; Of whom shall I be afraid? Psalm 27:1  

Some background of the vaccine for embryonated eggs

Vectored vaccines can be generated rapidly using recombinant techniques, and manufactured and purified quickly, allowing vaccine production in a short time. Development of non-replicating vectors further amplifies the safety margin and enhances the compliance rate.

Vaxin uses the PER.C6© cell line, licensed from the Dutch biotechnology company Crucell©, as the manufacturing substrate for production of RCA-free adenovirus-vectored vaccines.

The advantage of using this highly-characterized cell line is that it permits the production of high-titer recombinant adenovirus vectors that do not replicate in animals or humans. This is a very important feature in terms of product safety.

Moreover, Vaxin Scientists have developed the novel AdHigh system for rapid generation of RCA-free adenovirus vectors in PER.C6 cells within one month. The disadvantages associated with adenovirus vectors during gene therapy trials (e.g., transient transgene expression from the vector; hexon-mediated adjuvant effect) appear as remarkable advantages when the vector is used as a vaccine carrier.

Effective immunization by adenovirus-vectored nasal vaccines in the presence of pre-existing immunity to adenovirus has been demonstrated in animal models and early phase human studies.

In a phase I human clinical trial, a replication-defective adenovirus vector encoding an influenza hemagglutinin (HA) gene was administered to healthy volunteers. The adenovirus-vectored vaccine was safe when administered intranasally or topically. The immune response was more robust following intranasal delivery and provides the foundation for continued clinical development.

In addition to adenovirus-vectored vaccines, Vaxin Scientists have demonstrated that animals could be effectively immunized against live pathogens (e.g., Clostridium tetani cells and Bacillus anthracis spores) by topical application of non-replicating Escherichia coli (laboratory strains) vectors overproducing pathogen-derived antigens.

This novel vaccination modality is amenable to large-scale, rapid, low-cost production, distribution, and administration for vaccination in general, and specifically for mass immunizations.

Vaxin scientists and their associates have also shown that intranasal co-administration of adenovirus vectors encoding α-amyloid β-protein and granulocyte macrophage colony stimulating factor (GMCSF) could reduce amyloid load in the brain of transgenic Alzheimer mice without any appreciable side effects.

The impact of this development would be great if this approach should prove effective in human Alzheimer patients.

In addition to the development of human vaccines, Vaxin Scientists and their associates have effectively immunized chickens against avian influenza by in ovo inoculation of non-replicating adenovirus-vectored avian influenza vaccines.

This mode of vaccination is expected to emerge as a cost-effective approach for immunizing poultry en masse because adenovirus-vectored vaccines can be produced rapidly in response to emergence of new avian influenza virus strains.

Moreover, the non-replicating vector is not associated with any biohazards and can be administered into a large number of embryonated eggs by a robotic injector in a time- and labor-saving manner.


http://www.vaxin.com/Technology.htm

Disclaimer: poster has some Crucell shares....., make your own judgement!

OK, I'm officially confused. (Not an unusual circumstance.) Is this a vaccine for people, or for chickens? First they talk about Phase I human trials, and then they talk about cost-effective approach for immunizing poultry.

__________________ 
 

This company is developing both vaccines: human and poultry. In the other post the technology is explained.

Here they explain how they use the technology to develop a\ human vaccines (flu vaccine and a H5N1 vaccine):

Intranasal Influenza Vaccine

Influenza Vaccine is unique in that it behaves like a drug product in terms of sales growth. Re-vaccination is required yearly against the current strains of influenza. Increased awareness of the benefits of influenza vaccine, favorable public policy recommendations, and improvements in vaccine delivery are causing market growth.

Vaxin’s most advanced product candidate, a non-replicating adenovirus-vectored nasal influenza vaccine, has completed an initial Phase I clinical trial using a monovalent formulation. This study demonstrated safety and serological response when a recombinant adenovirus vector was used to deliver the influenza hemagglutinin (HA) gene by nasal administration (The influenza HA protein is the most important protective antigen in influenza vaccines; it is responsible for attaching the virus to the host cell during infection).

Cells transduced by adenovirus vectors, principally in the nasal mucosa, express the HA protein which stimulates an immune response. The immune response has been shown to include systemic antibodies, and is also expected to include local, mucosal antibodies.

Clinical dose escalation studies are planned for 2006 using monovalent and for 2007 using trivalent intranasal formulations of multiple influenza strains, followed by a phase II trivalent study. In addition, the National Institutes of Health (NIH) recently awarded Vaxin a $3 million Challenge grant in support of development of a non-replicating adenovirus-vectored nasal vaccine against a highly pathogenic avian influenza virus (H5N1) in preclinical animal studies.

Human clinical trials for this H5N1 influenza vaccine are expected to begin in 2007.

Vaxin’s influenza and avian influenza vaccines have the following advantages over products currently on the market or in development:

• Nasal delivery of a non-replicating vaccine without the concerns inherent in a replicating virus vaccine (e.g., FluMist) such as pathogenicity, reassortment, shedding and transmission.

• Likelihood of being indicated for a broader population including 50-64 year olds, the elderly (over 65 years old), and children including the very young (under 5 years old) due to the excellent safety profile of adenovirus-vectored nasal vaccines.

• More cost effective manufacturing: Vaxin’s product will be manufactured in cell culture. All currently marketed influenza vaccines (live or killed virus) require embryonated chicken eggs as a substrate for production. Inherent in the egg process are supply risks (e.g., avian flu outbreaks; limited supply of qualified eggs), low yield, and difficulty in manufacturing process control.

• More rapid response to changing influenza strains. Replacing the egg-based process with the PER.C6 cell culture manufacturing process will give Vaxin a start-up time advantage when an unexpected flu strain emerges after other manufacturers have exhausted their seasonal egg supply.

• Since Vaxin does not use eggs, there would not be a contraindication for contamination by chicken pathogens and allergic reactions to egg proteins.


http://www.vaxin.com/ProductDevelopment.htm

Vaccines for all H5N1 flu strains crucial -experts

11 Dec 2006 10:15:15 GMT

Source: Reuters

SINGAPORE, Dec 11 (Reuters) - The H5N1 bird flu virus has undergone many changes since making its first known jump into humans in 1997 and vaccines must be manufactured to fight its major strains, experts said on Monday.

While the virus remains largely a bird disease and does not infect people easily, the scientists at a conference on avian flu and other infectious diseases in Singapore warned against any complacency.

"What's worrying is there were more (human) cases in 2006 than 2004 and 2005. The problem is still with us," Robert Webster of the St Jude Children's Research Hospital in the United States told Reuters on the sidelines of the conference.

"It's (H5N1) continuing to evolve and there are multiple lineages of this virus still out there. What cross-protection is there between these clades (strains) and sub-clades?"

Webster said several H5N1 strains had become widespread and different enough to cause unease among experts, and no one would dare assume that any one vaccine would be able to protect against other H5N1 strains.

"They are sufficiently different so that we're all making vaccine strains against each one of these -- we are making a large number of vaccine strains in case any one of these became dominant," he said.

ENOUGH PROTECTION?

H5N1 has killed 154 people since 2003 and experts fear it might trigger a pandemic if it learns to transmit easily among people.

Derek Smith of Cambridge University in Britain said there have been at least five major changes to the H5N1 virus since it was first discovered in 1959.

These five strains were found in Hong Kong in 1997, Vietnam in 2004, Eurasia-Africa in 2005-2006, Indonesia in 2005 and Anhui province in China in 2005.

"It's not clear what is driving this antigenic evolution," Smith, research associate at Cambridge's zoology department, told the conference.

Several companies around the world are in a race to develop vaccines against the virus, although many experts think they might not confer protection against an eventual pandemic strain, if one should emerge.

Viruses mutate constantly and since vaccines are made based on a selected strain, they might not work as well against other strains.

Some experts at the conference also urged governments in the developing world to be realistic. In the event of a pandemic, there simply would not be vaccines or drugs for poorer nations.

"The world's vaccine production capability is about 350 million doses of flu vaccine per year, so it's going to reach only a very small population of the world," said Roy Anderson of the department of infectious disease epidemiology at Imperial College in London.

More time and resources should be spent instead on researching about, and promoting, simple hygiene measures "that might be beneficial to the majority of the world at very low cost", he said, citing the use of surgical masks, alcohol sprays and regular hand-washing.

http://www.alertnet.org/thenews/newsdesk/SP3291.htm

List of 31 on going trials pandemic influenza (oct. 2006)

http://www.ifpma.org/Influenza/cont...RnD_17Oct06.pdf

A Chinese female scientist has found the target sites to curb the bird flu influenza virus.

http://www.interfax.cn/displayartic...PRESS%20SUMMARY

This link www.bioon.com refers to a chinese article, don't know if it is interesting?

Nothing escapes you My skills in Chinese are non-existent however. Does anyone have any idea what could be meant by "target sites"? Something like the 'achilles heel' recently discovered in the virus' nucleoprotein?

http://www.bloomberg.com/apps/news?...uY&refer=europe

Novartis, Sanofi Seek Universal Influenza Vaccine (Update2)

By John Lauerman

Dec. 11 (Bloomberg) -- Novartis AG and Sanofi-Aventis SA are among drugmakers searching for new weapons against influenza viruses that evade protection from existing vaccines.

Each year, a new strain of the flu virus circles the globe and kills as many as a half million people. As the virus changes annually into forms that can circumvent the human immune system, scientists are seeking the first universal vaccine that will be effective against the mutations.

To defeat the flu, doctors will need vaccines with unprecedented power, said Albert Osterhaus, the head of virology at Erasmus University in Rotterdam. Such a vaccine should be able to protect against many strains at once, including the avian form arising in Asia that threatens to become a pandemic deadly to tens of millions of people.

``The real question is whether it's possible to do pre- pandemic vaccination or stockpile vaccine in advance of a pandemic,'' said Osterhaus, who helped organize a conference of flu experts gathering in Singapore this week to spur the quest.

The most recent flu pandemic, the 1968 Hong Kong flu, killed an estimated 34,000 people in the U.S. and at least a million worldwide. The 1918 Spanish flu, the largest flu wave on record, may have caused 50 million deaths globally. No one knows when the next pandemic will arrive or how devastating it will be.

The five-day conference, ``Respiratory Viruses of Animals Causing Disease in Humans,'' which runs through Dec. 14, is timely because the H5N1 avian flu has killed 154 people since late 2003, according to the World Health Organization. The virus, contracted mostly from the blood or excrement of infected poultry, threatens to mutate into a version that can spread easily between people. Such a virus would be lethal to many because humans don't have immunity against it.

Killer Virus

The H5N1 deaths have occurred in nine countries: Azerbaijan, Cambodia, China, Egypt, Indonesia, Iraq, Thailand, Turkey and Vietnam. A tenth, Djibouti, has had one confirmed human case, the WHO reports.

Vaccines are aimed at inducing immunity to disease. Much of the talk at the meeting is about chemicals, known as adjuvants, which boost the strength of existing types of vaccines.

``The most important question now is what is going to be the contribution of adjuvants to classical vaccines,'' Osterhaus said.

Novartis, based in Basel, Switzerland, uses an adjuvant called MF59 to beef up its Fluad vaccine. London-based GlaxoSmithKline Plc, Brussels-based Solvay SA, and Paris-based Sanofi Aventis also are experimenting with adjuvants.

Share Reaction

Novartis shares rose 55 centimes, or 0.8 percent, to 69.75 Swiss francs at the close of trading in Zurich. Shares of Glaxo fell 2 pence to 1,338 pence in London. Shares of Sanofi rose 45 cents, or 0.7 percent, to 69 euros in Paris.

While immune cells and proteins recognize and kill germs such as measles after a single confrontation, protection against the annually mutating flu must be given each year. The annual changes in the chemical structure of virus's eight genes can evade the human immune system's protective powers.

Almost a year before the U.S. flu season starts, germ trackers from the Geneva-based WHO and other public health groups begin sorting through viruses in Asia to find the three deemed most likely to move eastward and cause the next outbreak.

Sanofi, Glaxo, and Novartis take those strains, grow them in chickens' eggs, and then kill the virus to extract the proteins that go into vaccine shots.

Niagara Falls

``It's like choosing a boat to cross a continent,'' said Klaus Stoehr, a special adviser to the WHO, in a Dec. 5 interview in Boston. ``You hope one boat can get you across Niagara Falls and all the rivers.''

It takes at least six months to go from the selection of viruses by WHO laboratories to makers' shipping vaccine. Meanwhile, the viruses that remain spreading may continue to change into forms that can evade the new shots.

About once every three years, the virus that hits the U.S. mutates enough from the one used to make the vaccine to reduce the effectiveness of the shots, said Stanley Plotkin, an adviser to Sanofi and an organizer of the conference. Once every decade the match between virus and vaccine is enough to drop effectiveness by 70 percent.

``We expect fabulous protection from vaccines,'' said William Schaffner, an infectious-disease expert at Vanderbilt University in Nashville, Tennessee, and a consultant to the U.S. government. ``Influenza vaccines are not there yet.''

Stockpiled Vaccines

The WHO has warned that vaccines stockpiled to fight the next pandemic may not work. If the H5N1 virus does mutate into a form that spreads quickly in people, that version may bear little or no resemblance to the strains spreading today or those used to make vaccines.

Glaxo is trying to beat flu's elusiveness with adjuvant that has been shown to increase the power of a conventional flu shot, which contains parts of a killed virus, by about four times. Glaxo is developing the vaccine for multiple H5N1 types.

``The huge difference is that this is available now,'' said Emmanuel Hanon, head of Glaxo's worldwide flu franchise, in a Dec. 5 telephone interview. ``It will not take years to implement.''

Novartis, which acquired the MF59 adjuvant last year in its purchase of Chiron Corp., applied last month for a European license to use its H5N1 vaccine before a pandemic.

MedImmune's technology, which uses live, weakened flu virus, may offer advantages for immunization, WHO's Stoehr said. Whole virus grows quickly and provokes a strong immune response, he said, and the nasal-spray vaccine requires no needles to use.

Baxter's Work

Baxter International Inc., based in Deerfield, Illinois, is developing a whole-virus vaccine against a pandemic flu, Stoehr said. Baxter is growing batches of virulent H5N1 virus taken from infected people and animals, the killing the virus and putting it into vaccine. Baxter published research in October showing the vaccine works in low doses, without an adjuvant.

Sanofi said it will ship 50 million doses of seasonal flu to the U.S., making it the country's largest supplier. Novartis will provide 30 million doses and Glaxo will sell 25 million. Medimmune, which sells a nasal version, said it will ship 3 million doses this year, almost double last year's amount.

All of the shots need to show that they can safeguard humans if used before a pandemic begins, said Osterhaus, the conference organizer.

``We need to know if they indeed fulfill the promise of broader protection against different H5N1 viruses,'' he said. ``We need hard data.''

To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net .

Last Updated: December 11, 2006 13:46 EST

__________________ 
It's nature's way of receiving you
It's nature's way of retrieving you
It's nature's way of telling you
Something's wrong, something's wrong, something's wrong
Spirit 

EU Medicines Agency proposes authorisation for mock-up GSK pandemic flu vaccine

12.15.06, 6:31 AM ET

BRUSSELS (AFX) - The European Medicines Agency said it has proposed EU authorisation for a mock-up pandemic influenza vaccine.

The vaccine concerned, Daronrix from GlaxoSmithKline Biologicals SA, is intended for the prevention of influenza during a pandemic.

The EMEA said the objective behind a mock-up vaccine is to have marketing authorisation in place that can be changed quickly in the event of a pandemic to include the virus strain responsible.

The proposal will now go to the European Commission for a final decision

http://www.forbes.com/business/feed...afx3258083.html

UPDATE 1-European agency backs Glaxo pandemic flu shot

Fri Dec 15, 2006 6:39am ET


Updates with further details, Glaxo comment)

LONDON, Dec 15 (Reuters) - A first-generation experimental bird flu vaccine for use in humans from GlaxoSmithKline Plc (GSK.L: Quote, Profile , Research) has won outline support from European regulators.

The European Medicines Agency said on Friday it had recommended granting a license to Daronrix, a "mock-up" vaccine that could be used as the base for producing a shot to protect people in the event of a pandemic triggered by bird flu.

Daronrix is the first vaccine to have been given such endorsement.

It would be used once a pandemic had officially been declared by the World Health Organisation or the European Union, but it marks just one approach in vaccine preparations.

Glaxo, like several of its rivals, is also working on a second-generation vaccine against the H5N1 virus strain that causes bird flu and it said it planned to submit this product for regulatory approval within the next few weeks.

This second vaccine could potentially be used as part of a pre-pandemic vaccination campaign, helping to prepare the human immune system in advance of a pandemic.

The newer vaccine -- which Glaxo has already sold to some governments -- also has the added benefit of needing very little antigen to produce a strong immune response, allowing for production of large quantities for mass vaccination.

http://today.reuters.com/news/artic...XO-UPDATE-1.XML
.

European Medicines Agency Press office 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu

London, 15 December 2006
Doc. Ref. EMEA/502873/2006

PRESS RELEASE

European Medicines Agency adopts first positive opinion for mock-up pandemic influenza vaccine

The European Medicines Agency (EMEA) has adopted the first positive opinion recommending the granting of a Community authorisation for a mock-up pandemic influenza vaccine.

The objective behind a mock-up vaccine is to have a marketing authorisation in place that can be changed quickly in the event of a pandemic to include the virus strain responsible, once it has been identified.

The vaccine concerned, Daronrix from GlaxoSmithKline Biologicals S.A., is intended for the prevention of influenza during an officially declared pandemic situation, once the pandemic viral strain has been included. The mock-up pandemic influenza vaccine is not expected to be used or stockpiled in its current form.

The availability of vaccines in the event of an outbreak of pandemic influenza is essential for protecting the public from the disease. However, it is impossible to prepare an appropriate vaccine in advance of an outbreak, because the strain of the virus responsible for it is unknown until after the outbreak has started.

To facilitate the approval of pandemic vaccines, the European Commission and the EMEA developed a novel approach for the European Union that allows the authorisation of a mock-up vaccine in advance of a potential pandemic.

A mock-up pandemic influenza vaccine is a vaccine that mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method. Instead of the pandemic influenza virus strain, which is as yet unknown, the mock-up contains an influenza virus strain that has been specifically chosen because the population is immunologically naïve to it (i.e. a strain to which the population has never been exposed).

In the event of an influenza pandemic, the marketing authorisation holder will submit additional data as a variation to the marketing authorisation to include the actual pandemic virus strain in the vaccine.

The strain chosen for Daronrix is derived from a strain that has been involved in recent outbreaks of influenza in birds (H5N1). This strain is not circulating in humans.

The EMEA positive opinion on Daronrix will now be forwarded to the European Commission, which takes the final decision on the granting of a marketing authorisation.

--ENDS--

Notes
1. A question and answer document on mock-up vaccines can be found here.
2. The summary of opinion for Daronrix with more detailed information on the medicinal product is available here.
3. The EMEA pandemic influenza crisis management plan can be found here.
4. Guidelines for the preparation of pandemic influenza vaccines can be found here and here.
5. A core summary of product characteristics for pandemic influenza vaccines was adopted in 2005 and can be found here.
6. This press release together with other information about the European Medicines Agency can be found on the EMEA website:

http://www.emea.europa.eu

Media enquiries only to:

Martin Harvey Allchurch or Monika Benstetter

Tel. (44-20) 74 18 84 27, E-mail: press@emea.europa.eu

http://www.emea.eu.int/pdfs/general.../50287306en.pdf

Newcastle Disease Virus-Based Live Attenuated Vaccine Completely Protects Chickens and Mice from Lethal Challenge of Homologous
and Heterologous H5N1 Avian Influenza Viruses

Jinying Ge,1 Guohua Deng,1 Zhiyuan Wen,1 Guobing Tian,1 Yong Wang,1 Jianzhong Shi,1 Xijun Wang,1 Yanbing Li,1 Sen Hu,1 Yongping Jiang,1 Chinglai Yang,2 Kangzhen Yu,1 Zhigao Bu,1* and Hualan Chen1*

National Key Laboratory of Veterinary Biotechnology and Animal Influenza Laboratory of the Ministry of Agriculture, Harbin Veterinary Research Institute, Chinese Academy of Agricultural Sciences, 427 Maduan Street, Harbin 150001, People's Republic of China,1 Department of Microbiology and Immunology, Emory University School of Medicine, Rollins Research Center, Atlanta, Georgia 303222

Received 15 July 2006/ Accepted 9 October 2006

H5N1 highly pathogenic avian influenza virus (HPAIV) has continued to spread and poses a significant threat to both animal and human health. Current influenza vaccine strategies have limitations that prevent their effective use for widespread inoculation of animals in the field.

Vaccine strains of Newcastle disease virus (NDV), however, have been used successfully to easily vaccinate large numbers of animals. In this study, we used reverse genetics to construct a NDV that expressed an H5 subtype avian influenza virus (AIV) hemagglutinin (HA). Both a wild-type and a mutated HA open reading frame (ORF) from the HPAIV wild bird isolate, A/Bar-headed goose/Qinghai/3/2005 (H5N1), were inserted into the intergenic region between the P and M genes of the LaSota NDV vaccine strain. The recombinant viruses stably expressing the wild-type and mutant HA genes were found to be innocuous after intracerebral inoculation of 1-day-old chickens.

A single dose of the recombinant viruses in chickens induced both NDV- and AIV H5-specific antibodies and completely protected chickens from challenge with a lethal dose of both velogenic NDV and homologous and heterologous H5N1 HPAIV.

In addition, BALB/c mice immunized with the recombinant NDV-based vaccine produced H5 AIV-specific antibodies and were completely protected from homologous and heterologous lethal virus challenge.

Our results indicate that recombinant NDV is suitable as a bivalent live attenuated vaccine against both NDV and AIV infection in poultry.

The recombinant NDV vaccine may also have potential use in high-risk human individuals to control the pandemic spread of lethal avian influenza.

http://jvi.asm.org/cgi/content/abstract/81/1/150

credits Florida1

The 'holy grail' of flu vaccines
Daily Mail UK - Last updated at 22:20pm on 28th December 2006

by FIONA MacRAE
British scientists are on the verge of producing a revolutionary flu vaccine that works against all major types of the disease.

Described as the 'holy grail' of flu vaccines, it would protect against all strains of influenza A - the virus behind both bird flu and the nastiest outbreaks of winter flu.

Just a couple of injections could give long-lasting immunity - unlike the current vaccine which has to be given every year.

The brainchild of scientists at Cambridge biotech firm Acambis, working with Belgian researchers, the vaccine will be tested on humans for the first time in the next few months.

A similar universal flu vaccine, being developed by Swiss vaccine firm Cytos Biotechnology, could also be tested on people in 2007 - and the vaccines on the market in around five years.

Importantly, the vaccines would also be quicker and easier to make than the traditional jabs, meaning vast quantities could be stockpiled against a global outbreak of bird flu.

Martin Bachmann, of Cytos, said: "You could really stockpile it. In the case of a pandemic, that would be a huge advantage.

"If you were to start making a traditional vaccine at the start of a pandemic, there is no way there would be enough."

The Government believes a bird flu pandemic is inevitable, killing 50,000 people in Britain alone.

However, it acknowledges that the bug could be much more lethal - infecting one in two people and claiming more than 700,000 lives.

Normal winter flu can also kill, claiming up to 12,000 lives a year in the UK.

Although a vaccine exists, constant changes in the virus's appearance have until now made it impossible to create just one flu vaccine. Instead a new vaccine is put together each year to protect against the particular strains circulating at that time.

In addition, the virus used in the jab is grown in hen's eggs - a time-consuming process that yields just one shot of vaccine per egg.

The new jabs would be grown in huge vats of bacterial 'soup', with just two pints of liquid providing 10,000 doses of vaccine.

Current flu vaccines focus on two proteins on the surface of the virus. However, these constantly mutate in a bid to fool the immune system, making it impossible for vaccine manufacturers to keep up with the creation of each new strain.

The universal vaccines focus on a different protein called M2, which has barely changed during the last 100 years.

The protein is found in all types of Influenza A, including the current bird flu and the virus that caused the 1918 Spanish flu pandemic which killed up to 50 million across the globe.

Normally, such vaccines would have to go through at least five years of human tests before going on the market. However, if a bird flu pandemic occurs before that, they could be made more quickly available.

Zurich-based Cytos, which is also developing anti-smoking and obesity vaccines, has showed that its version of the jab stops mice dying from a dose of flu strong enough to kill them four-times over.

The vaccinated animals were also spared the fever that normally goes along with flu.

Although it is too early to say what the effect would be in humans, an initial course of two or three shots could provide long-lasting immunity, topped up with booster shots given every five to ten years.

Dr Ashley Birkett, of Acambis, said: "It wouldn't be that one shot protects for life but you would need fewer doses over your lifetime."

In addition, the jabs could be produced in vast quantities and stockpiled ahead of a flu pandemic - or even given to people in advance.

In contrast, a traditionally-produced vaccine, matched to the specific strain of flu, would not be available until around six months after the start of the pandemic.

The new vaccines only protect against influenza A - the version of the bug responsible for pandemic flu and the most severe cases of winter flu.

However, it may also be possible to create a similar jab against influenza B, which causes a milder form of winter flu.

Professor John Oxford, Britain's leading flu expert, said the development of a universal vaccine was the "holy grail" of flu research.

He added: "If you get a M2 vaccine which protects against the whole caboodle in the same vaccine, the possibilities are huge."

But, others cautioned that there is no guarantee that the jabs would be as effective in humans as it has been in animals.

Virologist Professor Ian Jones, of the University of Reading, said: "It is an encouraging technique which may have a role to play but it is too soon to assume that it will translate into a universal vaccine in the human population."

Dr Jim Robertson, a vaccine expert from the government-funded National Institute for Biological Standards and Control, said the main advantage of a universal jab would be lasting immunity.

"If it works, it will be lovely," he said. "The best result would be that it would last for a long, long time."

Dr Ron Cutler, an infectious diseases expert from the University of East London, said: "Continual protection would be a tremendous advantage against flu."

He cautioned however, that there is no guarantee that the M2 protein will not mutate in the future - meaning the jab will have to be regularly reformulated.

This is sweet news! I hope a few more articles are written that flesh out the technical details.

To think, the focus has been one trying to predict H's and N's all of these years and here is found a common, unchanging protein that can utilized in priming the immune system. So very cool!

First human tests begin of gene-based vaccine for bird flu

SCIENTISTS in the United States have begun the first human tests of a gene-based vaccine against a lethal strain of bird flu that some health experts fear may set off a pandemic capable of killing millions.
.
Tests have begun on 45 volunteers, the US National Institutes of Health said in an e-mailed statement yesterday.
.
The tests will determine if genes in the vaccine stimulate human cells to make proteins that prepare the immune system for infection with the H5N1 virus, said Mr Gary Nabel, director of the NIH's Vaccine Research Centre, where the preventive was designed.
.
At least 261 people, mostly in Asia, have been diagnosed with H5N1 bird flu since late 2003, and 157 of them have died, according to the World Health Organisation in Geneva.
.
DNA vaccines contain only genes, which can be produced quickly and cheaply, relative to conventional vaccines.
.
"An effective H5N1 influenza vaccine would provide a potentially life-saving advance against a global health threat," said Mr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, where the vaccine centre is based, in an e-mailed statement.
.
Manufacturers such as GlaxoSmithKline and Novartis grow conventional flu shots in chicken eggs or in animal cells.
.
With DNA vaccine, genes are shot into the body's cells on inert particles, such as gold. The genes then begin producing proteins that stimulate an immune response that prepares the body to fight an infection.
.
The DNA vaccine for bird flu is designed to protect against new strains of the virus that have arisen in Indonesia, Mr Nabel said in the statement.
.
Indonesia has had 57 human deaths from bird flu, the most of any country, according to the WHO.
.
The experiment "represents an example of our ability to respond to shifting viruses with modern technology", Mr Nabel said. — bloomberg
SCIENTISTS in the United States have begun the first human tests of a gene-based vaccine against a lethal strain of bird flu that some health experts fear may set off a pandemic capable of killing millions.
.
Tests have begun on 45 volunteers, the US National Institutes of Health said in an e-mailed statement yesterday.
.
The tests will determine if genes in the vaccine stimulate human cells to make proteins that prepare the immune system for infection with the H5N1 virus, said Mr Gary Nabel, director of the NIH's Vaccine Research Centre, where the preventive was designed.
.
At least 261 people, mostly in Asia, have been diagnosed with H5N1 bird flu since late 2003, and 157 of them have died, according to the World Health Organisation in Geneva.
.
DNA vaccines contain only genes, which can be produced quickly and cheaply, relative to conventional vaccines.
.
"An effective H5N1 influenza vaccine would provide a potentially life-saving advance against a global health threat," said Mr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, where the vaccine centre is based, in an e-mailed statement.
.
Manufacturers such as GlaxoSmithKline and Novartis grow conventional flu shots in chicken eggs or in animal cells.
.
With DNA vaccine, genes are shot into the body's cells on inert particles, such as gold. The genes then begin producing proteins that stimulate an immune response that prepares the body to fight an infection.
.
The DNA vaccine for bird flu is designed to protect against new strains of the virus that have arisen in Indonesia, Mr Nabel said in the statement.
.
Indonesia has had 57 human deaths from bird flu, the most of any country, according to the WHO.
.
The experiment "represents an example of our ability to respond to shifting viruses with modern technology", Mr Nabel said. — bloomberg SCIENTISTS in the United States have begun the first human tests of a gene-based vaccine against a lethal strain of bird flu that some health experts fear may set off a pandemic capable of killing millions.
.
Tests have begun on 45 volunteers, the US National Institutes of Health said in an e-mailed statement yesterday.
.
The tests will determine if genes in the vaccine stimulate human cells to make proteins that prepare the immune system for infection with the H5N1 virus, said Mr Gary Nabel, director of the NIH's Vaccine Research Centre, where the preventive was designed.
.
At least 261 people, mostly in Asia, have been diagnosed with H5N1 bird flu since late 2003, and 157 of them have died, according to the World Health Organisation in Geneva.
.
DNA vaccines contain only genes, which can be produced quickly and cheaply, relative to conventional vaccines.
.
"An effective H5N1 influenza vaccine would provide a potentially life-saving advance against a global health threat," said Mr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, where the vaccine centre is based, in an e-mailed statement.
.
Manufacturers such as GlaxoSmithKline and Novartis grow conventional flu shots in chicken eggs or in animal cells.
.
With DNA vaccine, genes are shot into the body's cells on inert particles, such as gold. The genes then begin producing proteins that stimulate an immune response that prepares the body to fight an infection.
.
The DNA vaccine for bird flu is designed to protect against new strains of the virus that have arisen in Indonesia, Mr Nabel said in the statement.
.
Indonesia has had 57 human deaths from bird flu, the most of any country, according to the WHO.
.
The experiment "represents an example of our ability to respond to shifting viruses with modern technology", Mr Nabel said. — bloomberg SCIENTISTS in the United States have begun the first human tests of a gene-based vaccine against a lethal strain of bird flu that some health experts fear may set off a pandemic capable of killing millions.
.
Tests have begun on 45 volunteers, the US National Institutes of Health said in an e-mailed statement yesterday.
.
The tests will determine if genes in the vaccine stimulate human cells to make proteins that prepare the immune system for infection with the H5N1 virus, said Mr Gary Nabel, director of the NIH's Vaccine Research Centre, where the preventive was designed.
.
At least 261 people, mostly in Asia, have been diagnosed with H5N1 bird flu since late 2003, and 157 of them have died, according to the World Health Organisation in Geneva.
.
DNA vaccines contain only genes, which can be produced quickly and cheaply, relative to conventional vaccines.
.
"An effective H5N1 influenza vaccine would provide a potentially life-saving advance against a global health threat," said Mr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, where the vaccine centre is based, in an e-mailed statement.
.
Manufacturers such as GlaxoSmithKline and Novartis grow conventional flu shots in chicken eggs or in animal cells.
.
With DNA vaccine, genes are shot into the body's cells on inert particles, such as gold. The genes then begin producing proteins that stimulate an immune response that prepares the body to fight an infection.
.
The DNA vaccine for bird flu is designed to protect against new strains of the virus that have arisen in Indonesia, Mr Nabel said in the statement.
.
Indonesia has had 57 human deaths from bird flu, the most of any country, according to the WHO.
.
The experiment "represents an example of our ability to respond to shifting viruses with modern technology", Mr Nabel said. — bloomberg

http://www.todayonline.com/articles/163980.asp