Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Associated Press - October 20, 2009
Marilynn Marchione, Associated Press
Yet the findings are exciting to scientists, who think that blood samples from the trial may show how to make a vaccine that does a better job.
The results also hint that the vaccine may work better in the general population than in those at higher risk of infection, such as gay men and intravenous drug users. It was the first time an AIDS vaccine was tested mostly in heterosexuals at average risk, and doctors have long known that how a person is exposed to HIV affects the odds of becoming infected.
"This study becomes a landmark. You can put it on a map and begin to figure out where you go from here," said Col. Jerome Kim, the U.S. Army doctor who co-led the trial.
Last month, researchers announced that a two-vaccine combination cut the risk of becoming infected with HIV by more than 31 percent in a trial of more than 16,000 volunteers in Thailand.
Full results, published online today by the New England Journal of Medicine and presented at a scientific conference in Paris, include two additional analyses that suggest the vaccine is merely beneficial, rather than providing definitive proof.
That's mostly because so few participants became infected - only 125 people, 10 times less than in previous HIV vaccine trials, said Dr. Anthony Fauci, director the National Institute of Allergy and Infectious Diseases, the study's main sponsor.
Critics had leaked one of the analyses last week, saying it showed the original results may have been a fluke. A California-based AIDS advocacy group criticized study leaders for not giving a fuller picture when they held their news conference last month.
"The bottom line is that those results are real," even though they are not good enough to justify using this vaccine now, said Dr. Alan Bernstein, executive director of the Global HIV Vaccine Enterprise, an alliance of governments, AIDS scientists, the World Health Organization and funders such as the Bill & Melinda Gates Foundation.
"We ... have evidence of protection, and the nitty-gritty (arguments) to me don't matter a damn," said Bernstein, who had no role in the trial.
Other scientists agreed. "It redirects the field to look at a different kind of vaccine," said Dr. Lawrence Corey of the University of Washington.
The Thailand Ministry of Public Health conducted this trial, which used vaccines made from strains of HIV common in Thailand. They are ALVAC, made by Sanofi Pasteur, and AIDSVAX, originally developed by VaxGen Inc. and now held by the nonprofit Global Solutions for Infectious Diseases. The vaccines are not made from whole virus and cannot cause HIV infection.
The combo was tested in HIV-negative Thai men and women ages 18 to 30 at average risk of becoming infected. Half received four doses of ALVAC and two of AIDSVAX over six months; the rest received dummy shots. All were given condoms and counseling, and were followed for three years after vaccination ended.
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 percent lower risk of infection for the vaccine group.
091020
AP091015
Copyright © 2009 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 2009. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .