HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorImmuno Cure Holding (HK) Limited
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Tested positive for HIV-1 antibody;
Aged 18-60, both male and female;
BMI (body mass index) in between 18.5 and 24.9 kg/m2 (including upper and lower limits);
Received ART for ≥12 months; no drug resistance occurred during this treatment period;
Disqualifiers
Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his/her spouse);
ART has been suspended for more than 2 weeks continuously since ART initiation;
Participated in other clinical trials within 24 weeks before the screening visit;
Has any opportunistic infections or opportunistic tumors that require systemic treatment within 30 days before being recruited; Has any medical events that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
Trial design
Design model
Parallel
Treatments tested in this trial
ICVAX (TERESA-EPT I device)
Biological/VaccineICVAX 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 (PharmaJet Tropis device)
Biological/VaccineICVAX will be administered intradermally using the PharmaJet Tropis device.
ICVAX (TriGrid device)
Biological/VaccineICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.
Treatment groups
22 Participants
are divided into 3 treatment groupsGroup A: Arm 1: ICVAX administration via TERESA-EPT I deviceExperimental treatment 1 intervention
Group B: Arm 2: ICVAX administration via PharmaJet Tropis deviceExperimental treatment 1 intervention
Group C: Arm 3: ICVAX administration via TriGrid deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety 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 3362
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 168Secondary outcomes
1
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 3362
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 336Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Immuno Cure Holding (HK) Limited
Lead sponsor
Immuno Cure 1 Limited
Collaborator
The University of Hong Kong
Collaborator
Source ClinicalTrials.gov