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NYU med school testing HIV vaccine in experiment
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Posted Tuesday, December 6 2005 10:57:49 pm
By Ali Weinberg, Washington Square News (NYU)
(U-WIRE) NEW YORK -- A new experimental HIV vaccine is being tested over the next four years at the Center for AIDS Research at New York University Medical Center, university officials said. The HIV vaccine was created by the Merck Pharmaceutical Company, which is sponsoring the study along with the U.S. National Institutes of Health's Division of AIDS and the HIV Vaccine Trials Network. NYU's Medical Center is one of five sites in New York conducting trials along with sites throughout the United States, South America, Canada, Australia and the Caribbean.
The study aims to determine whether the vaccine can reduce an HIV-negative individual's chance of becoming infected with the virus and also whether an HIV-infected person can become healthier after being vaccinated, said Robert Hagerty, a study coordinator at the Center for AIDS Research who is organizing NYU's component of the trial.
"Some vaccines work not by preventing infection, but by neutralizing infection," Hagerty said, referring to the possibility that the vaccine could improve the health of those already infected with the virus.
One division of the NYU study is targeting men and women with male sexual partners who are not infected with HIV. A separate trial will be conducted with different demographics of HIV-positive individuals, including groups of pregnant women and people with both HIV and hepatitis C, according to the medical schools' HIV information website.
Participants in the HIV-negative component of the study, who number 3,000 worldwide, will be monitored for four years after having received the injection and will meet with researchers every three months throughout the study, receiving $25 at each session.
With HIV-negative trials, neither the medical researchers nor the participants know if they are administering or receiving the actual vaccine or a placebo. Only Merck has this information, and participants will find out what injection they received at the end of the four-year trial, Hagerty said.
Hagerty said that at the end of the trial, a few trial participants will become infected with HIV because of their own sexual behavior.
"Unfortunately, despite our best efforts at [safe-sex] counseling, a small percentage of people will become infected over the next four years of the trial," Hagerty said. "It is among that small group of people that become infected at the end of the trial that the researchers will see how many got the vaccine and how many got the placebo."
Unlike most vaccines that are weakened versions of a virus, the vaccine does not contain any of the HIV virus, Hagerty said.
"With a flu shot, the vaccine is a weakened flu virus, and the worst that can happen is that people get the flu from it," he said. "We can't do that with HIV. The challenge for HIV vaccines has been how can you make a vaccine that looks like a live-virus vaccine."
To make the vaccine, scientists combined a weakened version of the adenovirus, which causes the common cold, with lab-generated copies of genes from the outer coating of the HIV virus, Hagerty said.
"I call it a Halloween costume," Hagerty said. "They dress up adenovirus to make it look like HIV to fool your body to think you've been infected."
The vaccine has proven safe in initial tests in which it was administered to 250 patients over a two-year period, none of which contract HIV from the vaccine.
Despite initial testing, participants should still review risks associated with the trial, said Dr. Jeffrey Dobken, an immunologist from Little Silver, N.J.
"The ethics community of NYU cannot give a harmful vaccine," Dobken said. But he suggested that volunteer participants should "get it in writing that it will not infect you."
Bert Leatherman, a third-year law student at NYU, volunteered for the HIV-negative trial last April, and said that follow-up meetings are fairly simply and consist of taking blood and questioning him about his recent sexual history.
"I feel very privileged to be able to work with leading HIV experts," Leatherman said. "I now have a better understanding of how the virus works."
Even though participants may have sex while taking the vaccine, researchers are not promoting reckless sexual behavior. In fact they will provide participants with safe sex counseling, Hagerty said.
"I want to emphasize that we don't tell anyone to go out and have unprotected sex," Hagerty added. "In all research studies that we are involved in, the safety of our volunteers comes first."
For information (NYU): 212 263-6565
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