NCT07530198

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Immuno Cure Holding (HK) Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Human Immunodeficiency Virus
• Human Immunodeficiency Virus I Infection

Interventions

Type	Name	Description
BIOLOGICAL	ICVAX (TERESA-EPT I device)	ICVAX is a HIV therapeutic DNA drug developed by Immuno Cure Group based on the PD-1-Enhanced DNA Vaccine Technology platform. ICVAX will be administered intramuscularly followed by electroporation using the TERESA-EPT I device.
BIOLOGICAL	ICVAX (PharmaJet Tropis device)	ICVAX will be administered intradermally using the PharmaJet Tropis device.
BIOLOGICAL	ICVAX (TriGrid device)	ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-03-31
• Completion: 2027-07-31
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Hong Kong