Safety and Immunogenicity of a PD-1-Enhanced HIV-1 Therapeutic DNA Vaccine: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Trial in People With HIV-1 on Antiretroviral Therapy.

In 30 seconds

This randomized, double-blind, placebo-controlled phase I trial evaluated the safety and immunogenicity of ICVAX™, a PD-1-enhanced HIV-1 therapeutic DNA vaccine, in 45 adults with HIV-1 on antiretroviral therapy. The study found that 83.3% of ICVAX recipients experienced mild treatment-related adverse events, and 75% of low-dose and mid-dose recipients achieved a ≥2-fold increase in peak ELISpot T-cell responses compared to 33.3% in the placebo group.

Key findings

• 83.3% of ICVAX recipients experienced mild treatment-related adverse events, compared to 100% in the placebo group.
• 75% of low-dose and mid-dose ICVAX recipients achieved a ≥2-fold increase in peak ELISpot T-cell responses.
• Only 33.3% of placebo recipients achieved a similar T-cell response increase.

Why it matters

The findings suggest that ICVAX may enhance immune responses in individuals with HIV-1, potentially offering a new therapeutic strategy for managing the virus without continuous antiretroviral therapy.