Lessons from the AIDSVAX B/B' Vaccine Efficacy Trial
Susan P. Buchbinder and Jonathan D. Fuchs
from: AIDS Vaccine Development: Challenges and Opportunities (Edited by: Wayne Koff, Patricia Kahn and Ian D. Gust). Caister Academic Press, U.K. (2007)
Abstract
We have much to learn from the North American Phase III trial of VaxGen's AIDSVAX B/B' vaccine, even though the vaccine proved to have no overall efficacy in preventing HIV-1 infection. The trial was statistically well-powered to provide clear answers on its primary and secondary endpoints, and met its goals in recruiting and retaining volunteers over the three-year study. Unfortunately, premature release of data suggesting vaccine efficacy in certain racial subgroups of the study population (based on statistically unadjusted analyses) caused considerable confusion in the field and the general public. It also highlighted the importance for future trials of selecting the most important subgroup analyses in advance and ensuring that the study has adequate statistical power to resolve them clearly. And it spotlighted the need to enroll volunteers reflecting the diversity of at-risk populations, and to utilize broad biostatistical expertise before releasing results to the media read more ...
