Human Immunodeficiency VirusPhase 1NCT07530198
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
A Phase 1 study testing ICVAX (TERESA-EPT I device), ICVAX (PharmaJet Tropis device) and ICVAX (TriGrid device) in people with Human Immunodeficiency Virus and Human Immunodeficiency Virus I Infection, run by Immuno Cure Holding (HK) Limited at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
- What is being tested?
- ICVAX (TERESA-EPT I device), ICVAX (PharmaJet Tropis device) and ICVAX (TriGrid device)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Mar 2026to 31 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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);
- Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;
- Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine > ULN, ALT or AST >1.5×ULN, hemoglobin < 11g/dL;
- Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
- Sensitive to electrical pulse stimulation, such as those who are implanted with pacemaker/ Automatic Implantable Cardioverter Defibrillator (AICD), or those who have wearable medical electronic devices including electrocardiogram;
- Needle phobia;
- Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;
- The investigator considers that he/she is not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital
Shatin, New Territories, 00000
Grace Chung Yan Lui, Dr., 55699539, gracelui@cuhk.edu.hk
Grace Chung Yan Lui, Dr.
About this study
Official title: 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
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.
- Being tested
- ICVAX (TERESA-EPT I device), ICVAX (PharmaJet Tropis device), ICVAX (TriGrid device)
- Keywords
- ICVAX, HIV, AIDS, DNA Vaccine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICVAX (TERESA-EPT I device)Biological
ICVAX is a HIV therapeutic DNA drug developed by Immuno Cure Group based on the PD-1-Enhanced DNA Vaccine Technology platform. ICVAX will be administered intramuscularly followed by electroporation using the TERESA-EPT I device.
ICVAX (PharmaJet Tropis device)Biological
ICVAX will be administered intradermally using the PharmaJet Tropis device.
ICVAX (TriGrid device)Biological
ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ICVAX administration via TERESA-EPT I device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TERESA-EPT I device. Receives: Biological: ICVAX (TERESA-EPT I device) |
| Arm 2: ICVAX administration via PharmaJet Tropis device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the PharmaJet Tropis device. Receives: Biological: ICVAX (PharmaJet Tropis device) |
| Arm 3: ICVAX administration via TriGrid device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TriGrid device. Receives: Biological: ICVAX (TriGrid device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ICVAX
To evaluate the incidence of adverse events and abnormal laboratory results within the period Day 0-Day 336.
Measured: Day 0-Day 336
Antigen-specific T Cell Response Induced by ICVAX
To evaluate the antigen-specific T cell responses induced by ICVAX within the period Day 0-Day 168 via ELISpot.
Measured: Day 0-Day 168
Secondary outcomes (2)
Humoral Immune Response of ICVAX
To evaluate humoral immune response of ICVAX within the period Day 0-Day 336 via ELISA.
Measured: Day 0-Day 336
Effect of ICVAX-ART Combined Treatment on Viral Reservoir
To evaluate the effect of ICVAX-ART combined treatment on the viral reservoir within the period Day 0-Day 336 via PCR.
Measured: Day 0-Day 336
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start30 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immuno Cure Holding (HK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immuno Cure 1 Limited, The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Grace Chung Yan Lui, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530198
- Sponsor's protocol ID
- ICVAX_HK202401
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of this study will be publicly disseminated by ways of publication(s) in peer-reviewed scientific journal(s), presentation(s) in scientific conference(s), posting on public clinical trial registry(ies) and/or otherwise instead of individual participant data (IPD) sharing.