NCT07530198 HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
| NCT ID | NCT07530198 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Immuno Cure Holding (HK) Limited |
| Condition | Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2026-03-30 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Grace Chung Yan Lui, Dr.
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT07530198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07530198 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07530198 currently recruiting?
Yes, NCT07530198 is actively recruiting participants. Contact the research team at gracelui@cuhk.edu.hk for enrollment information.
Where is the NCT07530198 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT07530198 clinical trial?
NCT07530198 is sponsored by Immuno Cure Holding (HK) Limited. The principal investigator is Grace Chung Yan Lui, Dr. at Chinese University of Hong Kong. The trial plans to enroll 22 participants.