Tuesday, November 03, 2009

Hurry Up And Wait:
Herpes Vaccine Trial Ending?

(image credit)

Herpes is so hot right now. All the cool kids have it and, really, it's not a big deal.* Unlike gonorrhea and chlamydia, it can't cause infertility over the long term; it doesn't eat your brain like syphilis, and it doesn't kill you like HIV or (occasionally) cause cancer like HPV. Really, herpes is the most friendly of the sexually transmitted infections. Of course, gonorrhea, chlamydia and syphilis are all curable with antibiotics if you get off your cookies and get tested already.

But as one of the lame, unpopular kids who doesn't have HSV-1 OR HSV-2, I am chomping at the bit to get the Herpevac vaccine, the clinical trial for which ends this month. This latest trial is a Phase 3 trial, which means the vaccine works and they are further investigating it. Here's the description from the NIH Clinical Trials database:
This study is a double-blind, randomized, controlled Phase III trial to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are herpes simplex virus (HSV)-1 and -2 seronegative. The primary efficacy objective is to evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 and/or HSV-2 between months 2 and 20 in healthy adult women who were initially HSV-1 and HSV-2 seronegative. The secondary efficacy objectives are to: evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 and/or HSV-2 occurring between the months 7 and 20; evaluate vaccine efficacy in the prevention of HSV-2 infection between months 2 and 20; and to evaluate vaccine efficacy in the prevention of HSV-2 infection occurring between months 7 and 20.
What they don't say is whether they are going to actually expose women to the herpes virus (presumably, that would be unethical) so I'm not sure how they could guarantee that the vaccine works if the women haven't been exposed. I guess they just assume the women in the trial are high risk enough or that herpes is prevalent enough that they will, at some point during the 20 months of the study, be exposed to the virus just by having sex.

So I don't know what's going on with this vaccine, but there are little bits of news that vaccines are being developed by companies and researchers at universities so maybe we'll know soon.

*Herpes IS a big deal if you transmit it to your baby during childbirth, and it can kill infants. But this rarely happens in the US. It may also increase your risk for HIV infection, because sores can leave skin broken and susceptible to the virus. But in most people who know they have herpes and who undergo treatment, the infection is completely manageable.

1 comment:

Anonymous said...

ah, good questions. indeed, in these types of vaccine studies, researchers do not expose folks to STIs or promote unsafe sex. in actuality, study volunteers are given a lot of safe sex counseling (and in HIV vaccine studies, high risk behaviors have been shown to go down because of this counseling). However, people will continue to have sex and some ladies in the study will get exposed to and contract herpes. They will have to have a pretty large sample size to ensure that the vaccine actually works under these "real life" conditions and isn't a statistical "blip". To do this, they will compare the number of herpes infections in the women receiving the vaccine vs. those receiving the placebo vaccine.