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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);