ICVAX therapeutic DNA vaccine for people living with HIV 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

This trial tests whether the ICVAX DNA vaccine, given with three different delivery devices, is safe and boosts HIV-specific T-cell responses in adults on stable antiretroviral therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Immuno Cure Holding (HK) Limited (Industry-sponsored)
• Locations: 1 site (Shatin, New Territories)
• Trial ID: NCT07530198 on ClinicalTrials.gov

What this trial studies

This Phase 1 randomized trial compares three delivery methods (TERESA-EPT I, PharmaJet Tropis, and TriGrid electroporation) for the ICVAX therapeutic DNA vaccine in adults with HIV on stable ART. Participants receive four injections at 4-week intervals and are monitored for immune responses through Day 168 and for safety through Day 336. The primary endpoints are safety and antigen-specific T-cell responses; enrollment targets adults aged 18–60 who meet viral load, CD4, and BMI criteria. The trial is conducted at the Chinese University of Hong Kong Phase 1 Clinical Trial Centre with oversight from local collaborators and the sponsor.

Who should consider this trial

Good fit: Adults 18–60 with HIV-1 who have been on stable ART for at least 12 months, have had viral load <50 copies/mL for ≥12 months, CD4 counts ≥350 cells/µL in the past 6 months, and a BMI of 18.5–24.9 are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have had recent ART interruptions, have low CD4 counts or known drug resistance, or recently participated in another clinical trial are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, ICVAX could safely boost HIV-specific T-cell immunity in people on ART, which might help the immune system control the virus more effectively.

How similar studies have performed: Previous therapeutic HIV DNA vaccines have sometimes produced immune responses but have not consistently achieved sustained viral control, so this approach remains experimental.

Eligibility criteria

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.

Where this trial is running

Shatin, New Territories

• The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Grace Chung Yan Lui, Dr. — Chinese University of Hong Kong
• Study coordinator: Grace Chung Yan Lui, Dr.

Conditions Human Immunodeficiency Virus; Human Immunodeficiency Virus I Infection; ICVAX; HIV; AIDS; DNA Vaccine