HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong

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.

Study Overview

• Status: Recruiting
• Conditions: Human Immunodeficiency Virus; Human Immunodeficiency Virus I Infection
• Intervention / Treatment: Biological: ICVAX (TERESA-EPT I device); Biological: ICVAX (PharmaJet Tropis device); Biological: ICVAX (TriGrid device)

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Grace Chung Yan Lui, Dr.; Phone Number: (852) 5569 9539; Email: gracelui@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong, 00000
      • Recruiting
      • The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital
      • Contact: Grace Chung Yan Lui, Dr.; Phone Number: 55699539; Email: gracelui@cuhk.edu.hk
      • Principal Investigator: Grace Chung Yan Lui, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Tested positive for HIV-1 antibody;
2. Aged 18-60, both male and female;
3. BMI (body mass index) in between 18.5 and 24.9 kg/m2 (including upper and lower limits);
4. Received ART for ≥12 months; no drug resistance occurred during this treatment period;
5. Had <50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
6. 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;
7. Adopted contraception method approved by the investigator from screening period until the end of study;
8. Understand the study and voluntarily sign the ICF.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his/her spouse);
2. ART has been suspended for more than 2 weeks continuously since ART initiation;
3. Participated in other clinical trials within 24 weeks before the screening visit;
4. 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;
5. 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;
6. Received approved vaccines within the past 3 months;
7. Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;
8. Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except local application);
9. Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;
10. Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine > ULN, ALT or AST >1.5×ULN, hemoglobin < 11g/dL;
11. Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
12. 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;
13. Needle phobia;
14. Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;
15. The investigator considers that he/she is not suitable to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: ICVAX administration via TERESA-EPT I device; 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.	Biological: ICVAX (TERESA-EPT I device); 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.
Experimental: Arm 2: ICVAX administration via PharmaJet Tropis device; 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.	Biological: ICVAX (PharmaJet Tropis device); ICVAX will be administered intradermally using the PharmaJet Tropis device.
Experimental: Arm 3: ICVAX administration via TriGrid device; 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.	Biological: ICVAX (TriGrid device); ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Humoral Immune Response of ICVAX	To evaluate humoral immune response of ICVAX within the period Day 0-Day 336 via ELISA.	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.	Day 0-Day 336

Collaborators and Investigators

• Sponsor: Immuno Cure Holding (HK) Limited
• Collaborators: The University of Hong Kong; Immuno Cure 1 Limited
• Investigators: Principal Investigator: Grace Chung Yan Lui, Dr., Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIV; AIDS; DNA Vaccine; ICVAX
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: ICVAX_HK202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No