Clinical trial results boost possibility of HIV vaccine

LYON,, France —From the time of its initial discovery by American and French scientists in 1981, AIDS has killed more than 25 million people worldwide, with an additional 33 million people living with HIV/AIDS. While advances in the development of drugs have transformed the disease from a certain death sentence to a chronic illness, it continues to cause devastation, particularly in sub-Saharan Africa, where many patients remain unable to afford medications and its prevalence threatens economic development.

But a late-stage clinical trial may have turned up something that researchers have awaited for nearly 30 years: an HIV vaccine that works.

Sanofi Pasteur, the vaccines division of French drug maker Sanofi-Aventis, announced that results of a 16,000-patient, phase 3 trial—conducted in Thailand over the last six years with sponsorship from the U.S. Army surgeon general and execution by the Thai Ministry of Public Health—indicated that a two-vaccine regimen for HIV is safe and “modestly” effective in preventing infection by the virus that causes AIDS.

According to final results, to be presented in Paris next month, the prime-boost combination of Sanofi Pasteur’s ALVAC HIV and VaxGen’s AIDSVAX B/E lowered the rate of HIV infection by 31.2% compared with placebo. “Albeit modest, the reduction of risk of HIV infection is statistically significant,” Sanofi Pasteur SVP research and development Michel DeWilde stated.

Though the news received a lot of attention in the media, some are not as excited. “Realistically, it doesn’t put them much closer to a vaccine than they were two years ago,” said Nick Saraniti, CEO and director of operations of Commcare Pharmacy, a specialty pharmacy in Fort Lauderdale, Fla. “It gives us the hope to keep trying.”

Saraniti noted that patients who took the vaccine contracted the virus 31.2% less often than those who didn’t. “What nobody knows is, were they a third less exposed as well?” Saraniti said.

Though pharmacists often administer vaccines for influenza, hepatitis A and hepatitis B, Saraniti said that any HIV vaccine that did reach the market likely would be administered in a clinical setting, perhaps under guidelines similar to that of Merck & Co.’s human papillomavirus vaccine Gardasil.

DeWilde said further work would be needed to develop and test a vaccine suitable for licensure and worldwide use.