Important note: Information in this article was accurate in March 2007. The state of the art may have changed since the publication date.
Merck HIV vaccine trial is unblinded
HIV Treatment Bulletin - Vol. 8, No. 11&12, November/December 2007
Round up of news posted to Treatment Action Group (TAG) basic science blog.
It was announced on 13 November that the STEP trial will be unblinded; all 3,000 participants will be told whether they received vaccine or placebo and informed of their anti-adenovirus antibody titer.
One of the unexplained results from this study is the higher rate of infections reported in patients receiving the active vaccine, and the disappointing lack of impact on viral load post infection.
Merck HIV Vaccine Trial: Data Presentations from the HVTN MeetingThe HVTN has quickly made data presentations regarding the Merck HIV vaccine efficacy trial results available online http://www.hvtn.org/science/1107.html
Introduction to the 502 Protocol
http://www.hvtn.org/fgm/1107slides/ANN_FGMStepintro.pdf [148 Kb]
Baseline characteristics of participants in the STEP trial
http://www.hvtn.org/fgm/1107slides/DAN_Demographics11_2.pdf [84 Kb]
STEP trial: efficacy analyses
http://www.hvtn.org/fgm/1107slides/Robertsonfinal.pdf [232 Kb]
Hypotheses for differential HIV acquisition rates
http://www.hvtn.org/fgm/1107slides/Buchbinder.pdf [248 Kb]
STEP study: summary of results
http://www.hvtn.org/fgm/1107slides/STEVESELF_FINAL_502_Summary_12NOV07.pdf [156 Kb]
A pathway toward understanding the biological basis for the vaccine efficacy results
http://www.hvtn.org/fgm/1107slides/McElrath.pdf [1.1 MB]
Roundtable intro: follow-up of participants in STEP
http://www.hvtn.org/fgm/1107slides/Roundtableintro.pdf [60 Kb]
Longer-term follow-Up for STEP/HVTN 502
http://www.hvtn.org/fgm/1107slides/FGM502LongertermfupGilbert.pdf [60 Kb]
Why we unblinded
http://www.hvtn.org/fgm/1107slides/Gray.pdf [604 Kb]
Source:
Richard Jeffreys Vaccine Prevention Blog
Related links: A Step Back? by Kristen Jill Kresge (IAVI report) HIV vaccine may have made people more vulnerable to HIV by Gus Cairns, from AIDSmap. Merck/HVTN Press Release
2008-11-01
IB070811-19
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