Actively Recruiting
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
Led by Immuno Cure Holding (HK) Limited · Updated on 2026-04-15
22
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
I
Immuno Cure Holding (HK) Limited
Lead Sponsor
I
Immuno Cure 1 Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tested positive for HIV-1 antibody
- Aged 18-60, both male and female
- BMI between 18.5 and 24.9 kg/m2 (inclusive)
- Received ART for at least 12 months with no drug resistance
- Plasma HIV RNA less than 50 copies/ml for at least 12 months before screening
- CD4+ T cells count at least 350 cells/µL in past 6 months and over 200 cells/µL before starting ART
- Using an approved contraception method from screening until study end
- Understand the study and voluntarily sign informed consent form
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy within two years
- ART interrupted for more than 2 continuous weeks since starting treatment
- Participated in other clinical trials within 24 weeks before screening
- Have opportunistic infections or tumors needing systemic treatment within 30 days before recruitment
- Have medical conditions affecting safety or immune response evaluation
- History of autoimmune diseases
- Allergic to components of the vaccine or have severe allergic reactions after administration
- Received approved vaccines within past 3 months
- Received blood products, immunoglobulins, or immunosuppressants within 12 weeks before recruitment
- Used interferon, systemic corticosteroids, or other immunosuppressants in last 3 months (except local use)
- Positive Hepatitis B surface antigen within 12 months or positive Hepatitis C antibody with confirmed infection
- Abnormal lab results such as low neutrophils, high creatinine, elevated liver enzymes, or low hemoglobin
- Physical or mental illness that may affect study completion
- Sensitivity to electrical pulse stimulation or implanted medical electronic devices
- Needle phobia
- Contraindications for intramuscular injections like thrombocytopenia or coagulation disorders
- Investigator considers participant unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital
Shatin, New Territories, Hong Kong, 00000
Actively Recruiting
Research Team
G
Grace Chung Yan Lui, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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