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

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.

NCT Number	NCT07530198
Lead Sponsor	Immuno Cure Holding (HK) Limited Collaborators: Immuno Cure 1 Limited, The University of Hong Kong
Conditions	Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
Enrollment	22 participants
Start Date	2026-03-30
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-15