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RECRUITING
NCT07530198
PHASE1

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

Sponsor: Immuno Cure Holding (HK) Limited

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2026-03-30

Completion Date

2027-07-31

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital

Shatin, New Territories, Hong Kong