HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong (NCT07530198) | Clinical Trial Compass
RecruitingPhase 1
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
Hong Kong22 participantsStarted 2026-03-30
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Had \<50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
✓. Had ≥350 cells/μL of CD4+ T cells in the past 6 months and \>200 cells/μL of CD4+ T cells before initiation of ART;
✓. Adopted contraception method approved by the investigator from screening period until the end of study;
✓. Understand the study and voluntarily sign the ICF.
Exclusion criteria
✕. 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;
✕. Has a history of autoimmune diseases; Has hypersensitivity to the components of this drug including ICVAX recombinant plasmid, NaCl, Na2HPO4 and NaH2PO4·H2O, and shows severe allergies, such as dyspnea, edema and other symptoms after administration;
✕. Received approved vaccines within the past 3 months;
✕. Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;
✕. Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except local application);