Actively Recruiting
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong: Evaluation of Immunogenicity and Safety of ICVAX in ART-treated Clinically Stable HIV-infected Patients
Led by Immuno Cure Holding (HK) Limited · Updated on 2026-04-15
22
Participants Needed
1
Research Sites
17 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
Researchers are evaluating the safety and immune response of a new HIV Therapeutic DNA Vaccine called ICVAX in adults living with HIV-1 who are already receiving antiretroviral therapy (ART). This Phase I clinical trial aims to compare three different methods of delivering the vaccine to see how well they stimulate specific T cell responses and to monitor safety over time. Participants will receive four doses of the ICVAX vaccine given at four-week intervals, administered through one of three devices: the TERESA-EPT I device, the PharmaJet Tropis device, or the TriGrid device. Each device delivers the vaccine differently, either intramuscularly with electroporation or intradermally. After the last dose, participants will be monitored for 36 weeks to assess both safety and immune responses. During the study, participants will be closely observed from day 0 through day 336 for safety, and T cell responses will be evaluated through day 168. Researchers will perform various assessments including immune response measurements and monitoring of viral reservoirs. The study involves multiple visits for vaccine administration and follow-up evaluations to understand how the vaccine interacts with ongoing ART treatment and to ensure participant safety throughout the trial.
CONDITIONS
Brief 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 to 60 years, male or female
- Body mass index (BMI) between 18.5 and 24.9 kg/m2
- Received antiretroviral therapy (ART) for 12 months or more without drug resistance
- Plasma HIV RNA less than 50 copies/ml for at least 12 months before screening
- CD4+ T cell count at least 350 cells/µL in past 6 months and above 200 cells/µL before ART
- Using investigator-approved contraception from screening until study end
- Understand the study and voluntarily sign informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women, or planning to give birth within two years (including spouse)
- ART stopped for more than 2 continuous weeks since starting treatment
- Participation in another clinical trial within 24 weeks before screening
- Opportunistic infections or tumors needing systemic treatment within 30 days before recruitment
- Medical conditions affecting safety or immune response evaluation
- History of autoimmune diseases or severe allergies to study components
- Received approved vaccines within 3 months prior
- Received blood products, immunoglobulins, or immunosuppressants within 12 weeks prior
- Use of systemic corticosteroids, interferon, or immunosuppressants within last 3 months (except local use)
- Positive Hepatitis B surface antigen or active Hepatitis C infection
- Abnormal lab results including low neutrophils, high creatinine, elevated liver enzymes, or low hemoglobin
- Physical or mental illness affecting study completion
- Sensitivity to electrical pulse stimulation or implanted/wearable electronic medical devices
- Needle phobia
- Contraindications to intramuscular injections such as bleeding disorders or anticoagulation therapy
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive the ICVAX HIV therapeutic DNA vaccine administered via one of three devices on Days 0, 28, 56, and 84.
4 visits for vaccine administration
Duration - Up to 6 months after the last vaccine dose
Participants are monitored for safety and immune responses following the vaccine treatment.
Visits as scheduled up to Day 336 for assessments
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.
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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