Outcomes for therapeutic vaccines trials

Abstract

The design of therapeutic vaccine clinical trials has not kept pace with clinical standards for HIV care. Future trials should evaluate immunogenicity, but also investigate the impact of vaccine-induced immune responses on viral replication and the clinical course. Ideally, the studies should aim to demonstrate non-inferiority to uninterrupted, fully suppressive highly active antiretroviral therapy and define virological failure as a sustained plasma viral load greater than 50-400 copies/ml.