Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • ICVAX (TERESA-EPT I device)
  • ICVAX (PharmaJet Tropis device)
  • ICVAX (TriGrid device)

Treatment groups

22 Participants
are divided into 3 treatment groups

Locations

1
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital00000, ShatinNew Territories, Hong Kong

Sponsors and collaborators

Immuno Cure Holding (HK) Limited

Lead sponsor

Immuno Cure 1 Limited

Collaborator

The University of Hong Kong

Collaborator

Source ClinicalTrials.gov