Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART

This study is focused on testing a new DNA vaccine called ICVAX for people living with HIV who are currently on antiretroviral therapy (ART). It aims to assess the safety, tolerability, and immune response (immunogenicity) of the vaccine in these individuals. The trial is important because it could potentially enhance the immune system's ability to fight the HIV virus, possibly improving long-term health outcomes for those with HIV. The study involves 45 participants who are stable on ART, offering an opportunity to explore new supportive treatments to complement existing ART regimens. Participants in the study are randomly assigned to receive different doses of the ICVAX vaccine or a placebo through an injection into the muscle, followed by a technique called electroporation to help the vaccine work better. This happens over several weeks, with injections at weeks 0, 4, 8, 12, and a booster at week 36. The study closely monitors participants for safety by tracking any side effects or unusual lab results. It also measures how well the vaccine stimulates the body's immune response, looking at both cellular and antibody reactions. Additionally, researchers will examine how the vaccine, combined with ART, may affect the amount of HIV present in the body.