Failed AIDS drug trials could harm future studies
Executives at Merck and AIDS researchers worldwide are still reeling from the recent announcement that a cold germ might be to blame for the once promising AIDS vaccine that was withdrawn from trial last month after research showed it may well increase risk of infection.
The vaccine, being tested across North America, South Africa and in several other locations across the world, was shown to cause more of the some 3,000 test subject who were given the vaccine to develop HIV than those who were given a placebo.
Now, the medical world is responding and, according to reports from Forbes magazine, among others, the news is fairly universal: a failed vaccine could and will most likely cause a drop off in the number of participants for future AIDS vaccine studies.
“That’s always a possibility, and that’s the reason why we have to be very transparent and open and honest, and be very energetic to educate people to understand just what went on here,” Dr. Anthony Fauci, an AIDS research pioneer and director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), told Forbes.
The institute was a partner in the trial.
“Already we have a lot of people misinterpreting that the vaccine itself actually gave [recipients] HIV infection — that’s impossible,” he said.
“We have a lot of education to do, and there’s always a danger that this could sour people on getting involved in vaccine trials.”
South African AIDS researchers have begun contacting the hundreds of volunteers who took part in the trials over recent months, warning them the vaccine could well make them more, not less, likely to contract the virus.
The move comes on the heels of an announcement last month by Merck Co. that an AIDS vaccine they were developing possibly caused more infections than it averted.
Of those given the vaccine, 19 contracted the virus as opposed to just 11 who were given the placebo.
Another expert agreed that the failed phase II trial of Merck Co.’s V520 vaccine runs the risk of scaring off participants and researchers.
“It’s a blow to the HIV prevention field,” Rowena Johnston, vice president of research at the Foundation for AIDS Research (amfAR) in New York City, told Forbes.
“Clearly, we want to be very careful that people aren’t thinking that AIDS researchers are going to be putting them at risk.”
Glenda Gray, lead researchers on the South African study, told the Washington Post this setback was enough to get her out of the field forever.
“This is my worst nightmare,” Ms Gray explained. “I haven’t slept for days. I have a headache. I’m ready to resign from trials for the rest of my life.”
While researchers say that the vaccine could not have caused HIV infection, it is possible the vaccine caused changes in the immune system which would make the virus easier to contract during later infection.
In the US the Merck vaccine trials took place in 15 cities including Boston, Los Angeles and New York.
Around the world, studies in Peru, Haiti and Australia were also conducted.
According to a spokesperson for Merck, most of the U.S. volunteers were gay men.
Ross von Metzke
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