HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong: Evaluation of Immunogenicity and Safety of ICVAX in ART-treated Clinically Stable HIV-infected Patients
The goal of this randomized clinical trial is to evaluate the safety and immunogenicity of the HIV Therapeutic DNA Vaccine (ICVAX) in participants with HIV-1 infection under antiretroviral therapy (ART). The study compares three delivery methods - Teresa -EPT I, PharmaJet Tropis, and PapiVax TriGrid EP - to induce antigen-specific T cell responses in the participants. The primary objectives are to evaluate the safety of ICVAX delivered using three different devices in the participants within the period Day 0-Day 336, and to evaluate the antigen-specific T cell responses induced by ICVAX in the participants within the period Day 0-Day 168. The participants will receive four injections of ICVAX administered at 4-week intervals. Following the final dose, participants will be monitored for 36 weeks.
• Tested positive for HIV-1 antibody;
• Aged 18-60, both male and female;
• BMI (body mass index) in between 18.5 and 24.9 kg/m2 (including upper and lower limits);
• Received ART for ≥12 months; no drug resistance occurred during this treatment period;
• Had \<50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
• Had ≥350 cells/μL of CD4+ T cells in the past 6 months and \>200 cells/μL of CD4+ T cells before initiation of ART;
• Adopted contraception method approved by the investigator from screening period until the end of study;
• Understand the study and voluntarily sign the ICF.