Phase 1 Study of HIV Therapeutic DNA Vaccine ICVAX to Test Safety and Immune Response in Adults with Stable HIV on ART in Hong Kong

What this Trial Is About

Researchers are evaluating the safety and immune response of a new HIV Therapeutic DNA Vaccine called ICVAX in adults living with HIV-1 who are already receiving antiretroviral therapy ART. This Phase I clinical trial aims to compare three different methods of delivering the vaccine to see how well they stimulate specific T cell responses and to monitor safety over time. Participants will receive four doses of the ICVAX vaccine given at four-week intervals, administered through one of three devices the TERESA-EPT I device, the PharmaJet Tropis device, or the TriGrid device. Each device delivers the vaccine differently, either intramuscularly with electroporation or intradermally. After the last dose, participants will be monitored for 36 weeks to assess both safety and immune responses. During the study, participants will be closely observed from day 0 through day 336 for safety, and T cell responses will be evaluated through day 168. Researchers will perform various assessments including immune response measurements and monitoring of viral reservoirs. The study involves multiple visits for vaccine administration and follow-up evaluations to understand how the vaccine interacts with ongoing ART treatment and to ensure participant safety throughout the trial.

HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong