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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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.
ICVAX will be administered intradermally using the PharmaJet Tropis device.
ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital
Shatin, New Territories, Hong Kong
RECRUITINGSafety of ICVAX
To evaluate the incidence of adverse events and abnormal laboratory results within the period Day 0-Day 336.
Time frame: Day 0-Day 336
Antigen-specific T Cell Response Induced by ICVAX
To evaluate the antigen-specific T cell responses induced by ICVAX within the period Day 0-Day 168 via ELISpot.
Time frame: Day 0-Day 168
Humoral Immune Response of ICVAX
To evaluate humoral immune response of ICVAX within the period Day 0-Day 336 via ELISA.
Time frame: Day 0-Day 336
Effect of ICVAX-ART Combined Treatment on Viral Reservoir
To evaluate the effect of ICVAX-ART combined treatment on the viral reservoir within the period Day 0-Day 336 via PCR.
Time frame: Day 0-Day 336
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