For first time, researchers report some AIDS vaccine success

Wolfman1982

people are hard to please
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not exactly GLBT news but still important enough for me to post it here.

http://www.latimes.com/news/nationworld/nation/la-sci-aids25-2009sep25,0,1263709.story

A vaccine combo reduced the number of new HIV infections in a study, Thai and U.S. researchers say.

By Thomas H. Maugh II

More than a quarter-century after scientists discovered the virus that causes AIDS, researchers have finally shown that an experimental vaccine can block at least some infections, marking the first small but significant step toward eventual control of this lethal pandemic.

The benefits of the vaccine were modest, only a 31% reduction in the number of new infections. But coming on the heels of previous vaccine studies that either showed no benefit at all or actually increased the risk of contracting the disease, the study buoys the hopes of researchers who had nearly given on ever finding an effective way to block the spread of the virus.

The results were released overnight in Bangkok, Thailand, where the research was conducted by a team including Thai researchers, the U.S. Army and the U.S. National Institutes of Health.

"This is a historic day in the 26-year quest to develop an AIDS vaccine," Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, who was not involved in the research, said in a statement.

"We now have evidence that it is possible to reduce the risk of HIV infection with a vaccine," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, in his own statement. "There is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit."

The trial, which began in 2003, had been disparaged by many critics as a waste of time and money because each of the two vaccines used in it had been shown in individual trials to produce no benefit. But researchers speculated that using them together, with one vaccine priming the immune system and the second boosting that response, would be more effective, and their optimism about this "prime-boost" combination has been validated.

Experts said that it will be many more years before a vaccine is available for wider use, but the results indicate at last that such a vaccine may, indeed, be possible. "It gives me cautious optimism," said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, which helped fund the study.

The primer in this combo is Alvac, made by Sanofi Pasteur, which uses a defanged canarypox virus to carry three synthetic HIV genes into the body. The boost comes from Aidsvax, originally made by VaxGen and now owned by the nonprofit group Global Solutions for Infectious Diseases. It contains a genetically engineered version of a protein from the HIV surface.

The study involved more than 16,000 volunteers in Thailand who had no unusual exposure to the virus, just the normal everyday risk. Half received four priming doses of Alvac and two boost doses of Aidsvax over a six-month period, and half received placebo shots.

After three years of follow-up, new HIV infections were observed in 74 of the 8,198 people who received the placebo, but in only 51 of the 8,197 given the vaccine, a statistically significant 31% reduction.

To the researchers' disappointment, however, the vaccine did not reduce levels of HIV activity in those who became infected after being vaccinated.

Full details of the study will be released next month at a conference in Paris.

The vaccine was made using strains of virus that circulate commonly in Thailand, so it is not clear whether it would have any benefit elsewhere in the world. The manufacturers have not said whether they will attempt to license their products in Thailand.

At least 33 million people worldwide are infected with the human immunodeficiency virus, which causes AIDS, and 25 million have died, according to the World Health Organization. An estimated 7,500 are infected each day.

Aidsvax had failed in two large trials halted in 2003, showing no benefit to recipients. Another trial by Merck & Co. of a different vaccine was halted in 2007 when researchers found that the vaccine might increase the risk of contracting the virus. more news from these links.
 
Experimental Vaccine Prevents Infection From HIV Virus

http://cbs2.com/national/hiv.vaccine.breakthrough.2.1204775.html

For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible.

The vaccine cut the risk of becoming infected with HIV by more than 31 per cent in the world's largest AIDS vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok.

Even though the benefit is modest, "it's the first evidence that we could have a safe and effective preventive vaccine," Col. Jerome Kim said in a telephone interview. He helped lead the study for the U.S. Army, which sponsored it with the National Institute of Allergy and Infectious Diseases.

The institute's director, Dr. Anthony Fauci, warned that this is "not the end of the road," but said he was surprised and very pleased by the outcome.

Read More About The Experimental Vaccine

Vaccine Coalition

UNAIDS

Government AIDS Information


"It gives me cautious optimism about the possibility of improving this result" and developing a more effective AIDS vaccine, Fauci said in a telephone interview. "This is something that we can do."

Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people worldwide are newly infected with HIV; 2 million died of AIDS in 2007, the U.N. agency UNAIDS estimates.

"Today marks an historic milestone," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, an international group that has worked toward developing a vaccine.

"It will take time and resources to fully analyze and understand the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field," he said in a statement.

The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Whether such a vaccine would work against other strains in the U.S., Africa or elsewhere in the world is unknown, scientists stressed.

CBS News correspondent Elizabeth Palmer reports that the study actually tested a combination of two older, failed vaccines in conjunction with one another. Researchers called it a "prime-boost" approach, where the first one primes the immune system to attack HIV and the second one strengthens the response.

Palmer adds that scientists have made it very clear this new treatment will not be available for general medical use any time soon, but the study's results will likely draw more funding for continued research at a time when much of the medical community was starting to have serious doubts.

CBS News medical correspondent Dr. Jennifer Ashton explains that for a vaccine to be given public health approval, it generally needs to be proven effective in 50 to 80 percent of cases, where as this trial vaccine combo only worked in about a third of cases.

However, Ashton told Early Show co-anchor Harry Smith the study is incredibly important to the medical community because it shows that even after 30 years-plus of AIDS research, new breakthroughs are still happening.

The two medicines used in this trial are ALVAC, from Sanofi Pasteur, the vaccine division of French drugmaker Sanofi-Aventis; and AIDSVAX, originally developed by VaxGen Inc. and now held by Global Solutions for Infectious Diseases, a non-profit founded by some former VaxGen employees.

ALVAC uses canarypox, a bird virus altered so it can't cause human disease, to ferry synthetic versions of three HIV genes into the body. AIDSVAX contains a genetically engineered version of a protein on HIV's surface. The vaccines are not made from whole virus - dead or alive - and cannot cause HIV.

Neither vaccine in the study prevented HIV infection when tested individually in earlier trials, and dozens of scientists had called the new one futile when it began in 2003.

"I really didn't have high hopes at all that we would see a positive result," Fauci confessed.

The results proved the skeptics wrong.

"The combination is stronger than each of the individual members," said the Army's Kim.

The study tested the combo in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four "priming" doses of ALVAC and two "boost" doses of AIDSVAX over six months. The others received dummy shots. No one knew who got what until the study ended.

All were given condoms, counselling and treatment for any sexually transmitted infections, and were tested every six months for HIV. Any who became infected were given free treatment with antiviral medicines.

Participants were followed for three years after vaccination ended.

Results: New infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots. That worked out to a 31 per cent lower risk of infection for the vaccine group.

The vaccine had no effect on levels of HIV in the blood of those who did become infected. That had been another goal of the study - seeing whether the vaccine could limit damage to the immune system and help keep infected people from developing full-blown AIDS.

That result is "one of the most important and intriguing findings of this trial," Fauci said. It suggests that the signs scientists have been using to gauge whether a vaccine was actually giving protection may not be valid.

"It is conceivable that we haven't even identified yet" what really shows immunity, which is both "important and humbling" after decades of vaccine research, Fauci said.

Details of the $105 million study will be given at a vaccine conference in Paris in October.

This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS. In 2007, Merck&Co. stopped a study of its experimental vaccine after seeing it did not prevent HIV infection. Later analysis suggested the vaccine might even raise the risk of infection in certain men. The vaccine itself did not cause infection.

In 2003, AIDSVAX flunked two large trials - the first late-stage tests of any AIDS vaccine at the time.

It is unclear whether vaccine makers will seek to license the two-vaccine combo in Thailand. Before the trial began, the U.S. Food and Drug Administration said other studies would be needed before the vaccine could be considered for U.S. licensing.

Also unclear is whether Thai volunteers who received dummy shots will now be offered the vaccine. Researchers had said they would do so if the vaccine showed clear benefit - defined as reducing the risk of infection by at least 50 per cent.

Those issues, plus how to proceed with future studies, will be discussed among the governments, study sponsors and companies involved in the trial, Kim said. Scientists want to know how long will protection last, whether booster shots will be needed, and whether the vaccine helps prevent infection in gay men and injection drug users, since it was tested mostly in heterosexuals in the Thai trial.

The study was done in Thailand because U.S. Army scientists did pivotal research in that country when the AIDS epidemic emerged there, isolating virus strains and providing genetic information on them to vaccine makers. The Thai government also strongly supported the idea of doing the study.

(© 2009 CBS Broadcasting Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.)
 
Sigh, I used to work in a nonprofit clinic that did AIDs research... remember every day hoping for some type of cure for this, or at least a glimmer of light.
 
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