HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2026
CompletedFirst Submitted
Initial submission to the registry
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
April 15, 2026
April 1, 2026
1 year
April 1, 2026
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of ICVAX
To evaluate the incidence of adverse events and abnormal laboratory results within the period Day 0-Day 336.
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.
Day 0-Day 168
Secondary Outcomes (2)
Humoral Immune Response of ICVAX
Day 0-Day 336
Effect of ICVAX-ART Combined Treatment on Viral Reservoir
Day 0-Day 336
Study Arms (3)
Arm 1: ICVAX administration via TERESA-EPT I device
EXPERIMENTALParticipants 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.
Arm 2: ICVAX administration via PharmaJet Tropis device
EXPERIMENTALParticipants 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.
Arm 3: ICVAX administration via TriGrid device
EXPERIMENTALParticipants 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.
Interventions
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 will be administered intradermally using the PharmaJet Tropis device.
ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immuno Cure Holding (HK) Limitedlead
- Immuno Cure 1 Limitedcollaborator
- The University of Hong Kongcollaborator
Study Sites (1)
The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital
Shatin, New Territories, 00000, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grace Chung Yan Lui, Dr.
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2026
First Posted
April 15, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.