Failed Merck vaccine may have made intact men more vulnerable; rethink is in order, researchers say [updated]

[Dr. Susan Buchbinder] reported at the [15th CROI] conference today that further analysis of the Merck study results found that uncircumcised volunteers who received the vaccine ran nearly 4 times the risk of infection than those who were given a placebo.

Buchbinder said one possible explanation is that the vaccine somehow activated white blood cells near the surface of the foreskin - known HIV targets - making them more vulnerable to infection. She told reporters that she would not recommend at this time that study participants who are uncircumcised and received the vaccine, rather than a placebo, be circumcised as a precaution.

Follow-up research has also shown that the slight trend toward higher infection rates among all those who took the vaccine has not yet abated. But the number of infections involved is so low that there remains a possibility that the higher infection rates among uncircumcised men was purely the result of chance.

A vaccine trial that made volunteers more vulnerable to HIV that then would encourage circumcision is insult to injury for the unfortunates who received the ill-fated vaccine candidate.

A rethinking is in order, no doubt about it. But the rethink, at least in the developed world, is that HIV/AIDS is 100% avoidable. This virus may be beyond us, but it is infinitely containable. We know more than enough to shift some of the burden that researchers are feeling onto the shoulders of the community. We all have to take responsibility for avoiding this virus.

If some ADULTS want circumcision as part of this process, they should have it. The challenge then is how to maintain the responsibility on the adult individual, the only place where it can work. The danger is that the temptation will be to shift the decision from the individual to someone else, such as doctors and parents. Ethically, that is the wrong path to take, and ultimately another ill-effect of the virus, but which is within the power of humans to avoid.

Link: Failure to find AIDS vaccine has researchers seeking new directions.

Aidsmap, the best source of information on HIV/AIDS in the English language, has a better analysis of the Merck vaccine failure. Their article includes details of a discussion that the failed vaccine may have deactivated the protective mechanism in the mucosal tissue of the foreskin.

I think it is important to realize what the difference between the intact and circumcised seroconverters was in real numbers: 49 versus 33, respectively, out of 930 male volunteers. That's a tiny group, conclusions from which would seem ill-advised.

UPDATE: Forty-nine people in the vaccine trial group seroconverted. Thirty-three in the control group also seroconverted. Therefore, the difference between the circumcised and intact group who seroconverted is even smaller than the difference between the trial and control group. The numbers here are miniscule with no statistical significance. That wasn't made clear in the earlier reports. And it was glossed over by the largely circumcision positive press.

Link: Aidsmap | CROI: AIDS vaccine: additional [increased] infection risk restricted to uncircumcised men.

Comments

[Joe in CA]

So the moral of the story?

Circumcise men so that they might benefit from Merck's vaccine.

(?!)

[David]

No. Circumcised men had a greater seroconversion rate as well. Intact men on the placebo did not seroconvert at greater rates. Keep in mind this was largely a gay male population which has been shown recently in three separate studies not to benefit from circumcision.

The vaccine utterly failed for everyone.