RecruitingPhase 1NCT07530198

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


Sponsor

Immuno Cure Holding (HK) Limited

Enrollment

22 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called ICVAX (PharmaJet Tropis device), a biological treatment called ICVAX (TERESA-EPT I device), and others for people with human immunodeficiency virus and human immunodeficiency virus i infection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALICVAX (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.

BIOLOGICALICVAX (PharmaJet Tropis device)

ICVAX will be administered intradermally using the PharmaJet Tropis device.

BIOLOGICALICVAX (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

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NCT07530198


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