Merck HIV vaccine trial is unblinded

1 December 2007. Related: Vaccines and microbicides.

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 Meeting

The HVTN has quickly made data presentations regarding the Merck HIV vaccine efficacy trial.
http://www.hvtn.org/science/1107.html

Introduction to the 502 Protocol
http://www.hvtn.org/fgm/1107slides/ANN_FGMStepintro.pdf

Baseline characteristics of participants in the STEP trial
http://www.hvtn.org/fgm/1107slides/DAN_Demographics11_2.pdf

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

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

Longer-term follow-Up for STEP/HVTN 502
http://www.hvtn.org/fgm/1107slides/FGM502LongertermfupGilbert.pdf

Why we unblinded
http://www.hvtn.org/fgm/1107slides/Gray.pdf