In Pursuit of an HIV Vaccine: Designing Efficacy Trials in the Context of Partially Effective Non-Vaccine Prevention Modalities.

Publication Type:

Journal Article


AIDS research and human retroviruses (2013)


2013, May 2013, Public Health Sciences Division, Vaccine and Infectious Disease Division


The HIV prevention landscape is evolving rapidly, and future efficacy trials of candidate vaccines, which remain the best long-term option for stemming the HIV epidemic, will be conducted in the context of partially effective non-vaccine prevention modalities. It is essential that these trials provide for valid and efficient evaluation of vaccine efficacy and immune correlates. The availability of partially effective prevention modalities presents opportunities to study their interactions with vaccines to maximally reduce HIV incidence. This manuscript proposes an approach for conducting future vaccine efficacy trials in the context of background use of partially effective non-vaccine prevention modalities, and for conducting future vaccine efficacy trials that provide non-vaccine prevention modalities in one or more of the randomized study groups. Strategies are discussed for responding to emerging evidence on non-vaccine prevention modalities during ongoing vaccine trials. Next-generation HIV vaccine efficacy trials will almost certainly be more complex in their design and implementation but may become more relevant to at-risk populations and better-suited to the ultimate goal of reducing HIV incidence at the population level.