HIV Therapeutic Vaccine Trial Demonstrates the Importance of Placebo Controls

One of the strategies being pursued to induce antiretroviral therapy (ART)–free remission in people with HIV is therapeutic vaccination. Investigators at the NIH now report the results of a therapeutic vaccine trial conducted in participants who had initiated ART during acute or early infection.

Participants were randomized to receive placebo (n=16) or a therapeutic vaccine (n=15). The intervention consisted of priming with a plasmid DNA (pDNA) vaccine containing genes encoding multiple HIV proteins, followed by boosting with an attenuated viral vector expressing a single HIV gene. After completing the injections, ART was stopped for 16 weeks with careful monitoring. Criteria for restarting ART included sustained HIV RNA levels >50,000 copie…