Merck’s HIV Vaccine May Have Raised Infection Risk
4 CommentsBy Ed Silverman // November 7th, 2007 // 3:33 pm
Two weeks ago, we wrote that Merck’s failed HIV vaccine may have actually caused some clinical trial participants to become infected, and the 3,000 volunteers should be tested. As it turns out, a subset of patients developed the virus at a higher rate than those given a placebo, and all of them were HIV-negative at the start of the trial. Most likely, the vaccine made the body’s immune system more vulnerable.
For a vaccine that was tested for prevention, this is a cruel irony. And the numbers are sobering. Overall, as of mid-October there were 49 cases of HIV infection among the 914 male volunteers in the vaccine group, compared with 33 cases among the 922 males in the placebo group, according to a Merck statement.
The participants who were more suspectible began the study with a pre-existing immunity to the cold virus from which the vaccine is made. Among 778 men who had high levels of pre-existing immunity, there were 21 infections among those who received the vaccine and nine among those who received the placebo. The data was presented today at a Seattle conference of the HIV Vaccine Trials Network, which co-sponsored the NIH-funded study.
“There seem to be more cases in those who were actually vaccinated,” Keith Gottesdiener, Merck’s vp of vaccine and infectious-disease clinical research, tells The Wall Street Journal. “We don’t really know the reasons for this. We’re still studying very hard to try to understand why that might have occurred.”
Cary
With the way things are going at the FDA, if they sent the vaccine in today it would probably get approved. I would like to know how these people were propositioned for this study.
Study rep: “You will be financially compensated for your time and money during the study period and will receive all medication and data related to the trail at no expense. The study period will last 15 to 20 weeks and there is a chance of becoming HIV (cough!!) positive.”
Jack
Interesting and unfortunate.
Do we know if the 21 cases in the active treatment group is statistically higher than the 9 who received placebo, or is it just not a statistical improvement compared to the placebo?
The immune systems a funny system, and activation of some components of the immune system serve to down regulate it. I wonder if this vaccine, or vaccine formulation, preferentially triggered the immunosuppresent side of the immune system. But it still seems most likely to me the vaccine just doesn’t work, and that the higher number of cases in the active group is just an anomaly.
Friday Blog Roundup « The Pump Handle
[...] Ed Silverman at Pharmalot has the latest on Merck’s failed HIV vaccine, which seems to have made some clinical trial participants’ immune systems more vulnerable. [...]
wak
I was apart of this test and became HIV poz and strongly believe it broke my immune system down and left me open to get HIV and i wounder what else it might have don to my body after each shot i had very bad side affects alot of them! each time i was reviewed I would teel them and then said that i dont wont to take no more shots and wanted to end my participation they keep calling me and teeling me it was just side afects nothing to worry about i wish i would have listen to my inter self! i did stop but not before all my shots but not to mention future problems besides hiv dos anybody know any other problems besides hiv thank you