AIDS Clinical Trials Group 5197: A Placebo‐Controlled Trial of Immunization of HIV‐1–Infected Persons with a Replication‐Deficient Adenovirus Type 5 Vaccine Expressing the HIV‐1 Core Protein

The vaccine was generally safe and well tolerated. Despite a trend favoring viral suppression among vaccine recipients, differences in HIV-1 RNA levels did not meet the prespecified level of significance. Induction of HIV-1 gag-specific CD4 cells correlated with control of viral replication in vivo. Future immunogenicity studies should require a substantially higher immunogenicity threshold before an ATI is contemplated.