GSK Herpes Vaccine Trial

[k-ho]

So I was involved in the trial for this vaccine at my university starting in 2007, and we all received either the herpes vaccine or a variation (in dose and timing) of the hep A vaccine. Is that still considered a placebo? What do you call that?

It's supposedly becoming unblinded this fall, but the research team has been changing that every time I ask. I have had a hard time finding info on it, does anyone here research in this general area and know anything? We all will have the chance to get the vaccine if we got the hep A one instead.

I've heard that it's anywhere from 50-90% effective as well, which I'm sure involves lots of variables, including how many of the 3 doses a person has received.

Also, I'm guessing we can expect the usual maelstrom of opposition to this vaccine from the religious right and anti-vacc crowd (of course), but I haven't heard anything preemptively. Has anyone else?

 

[Hellbound]

Using a known vaccine as a control is fairly typical. The reason is that many vaccines can cause some symptoms, such as a low-grade fever, pain and swelling at the injection site, and similar things. If they used (for example) regular saline, it would be fairly easy for researchers, or informed patients, to determine whether they recieved a placebo or the actual vaccine.

I haven't heard anything else, but thought I'd help on that point. fls, one of the posters here, seems to be pretty knowledgeable in this area. Perhaps she might come along and post some thoughts on the subject

 

[k-ho]

Yes that makes sense. Of course, we were all probably hoping we got the Herpevac....

 

[fls]

Using a known vaccine as a control is fairly typical. The reason is that many vaccines can cause some symptoms, such as a low-grade fever, pain and swelling at the injection site, and similar things. If they used (for example) regular saline, it would be fairly easy for researchers, or informed patients, to determine whether they recieved a placebo or the actual vaccine.

It varies. You can usually count on symptoms in a placebo vaccine anyway, but placebos which have some activity (just not the activity of interest) are frequently used in order to help with blinding. However, this shouldn't really be necessary if you are dealing with 'hard' endpoints such as the presence or absence of herpes ulcers or antibody responses.

I haven't heard anything else, but thought I'd help on that point. fls, one of the posters here, seems to be pretty knowledgeable in this area. Perhaps she might come along and post some thoughts on the subject

I don't really know anything specific about this trial or why they chose this particular control. And I don't know anything about the timeline. If I've got the right trial, it says it was completed on November 2009 on the clinical trials site, but I don't know if that means recruitment (in which case there would be 20 months of follow-up) after that, or if that is when the last follow-up was completed. No study results have been posted yet.

http://clinicaltrials.gov/ct2/show/NCT00057330?term=herpevac&rank=2

Linda

 

[k-ho]

I suppose I'll just have to be patient.

Thanks!