A Phase 1 interventional study of ICVAX and Placebo in Human Immunodeficiency Virus and Human Immunodeficiency Virus I Infection, sponsored by Immuno Cure Holding (HK) Limited. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Immuno Cure Holding (HK) Limited · Phase 1, Interventional, and Treatment
The clinical trial is a dose-escalation, randomized, double-blind, placebo-controlled phase I study at a single center to evaluate the safety, tolerability and immunogenicity of HIV Therapeutic DNA Vaccine, ICVAX, in clinically stable HIV patients under ART treatment.
This is a dose-escalation, randomized, double-blind, placebo-controlled phase I study at a single center to evaluate the safety, tolerability and immunogenicity of HIV Therapeutic DNA Vaccine, namely ICVAX, in clinically stable HIV patients under ART treatment. 45 patients will be randomized and divided equally into 3 groups to receive either 1, 2, or 4 mg vaccine or the same volume of placebo at 4:1 ratio via intramuscular injection followed by electroporation at 0, 4th, 8th, 12th week, followed by a 24-week follow-up period. The 5th administration (booster injection) will be conducted at 36th week and subjects will be followed for another 24 weeks. The primary endpoint is safety evaluation of ICVAX in clinically stable HIV-infected patients under ART. The incident rate of adverse events and abnormal laboratory results will be recorded for safety evaluation. The secondary endpoint is immunogenicity evaluation of ICVAX. Antigen-specific cellular and humoral immune responses induced by ICVAX, as well as the effect of ICVAX-ART combined treatment on the viral reservoir, will be assessed.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 45 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Immuno Cure Holding (HK) Limited is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Clinically stable HIV-infected patients under ART treatment will receive 1 mg/dose ICVAX or Placebo at 4:1 ratio. ICVAX and Placebo will be administered via intramuscular injection followed by electroporation at 0, 4th, 8th, 12th, and 36th week.
Biological: ICVAX · Other: Placebo
Clinically stable HIV-infected patients under ART treatment will receive 2 mg/dose ICVAX or Placebo at 4:1 ratio. ICVAX and Placebo will be administered via intramuscular injection followed by electroporation at 0, 4th, 8th, 12th, and 36th week.
Biological: ICVAX · Other: Placebo
Clinically stable HIV-infected patients under ART treatment will receive 4 mg/dose ICVAX or Placebo at 4:1 ratio. ICVAX and Placebo will be administered via intramuscular injection followed by electroporation at 0, 4th, 8th, 12th, and 36th week.
Biological: ICVAX · Other: Placebo
ICVAX is a HIV therapeutic DNA drug developed by Immuno Cure Group based on the PD-1-Enhanced DNA Vaccine Technology platform. The unit dose strength is 2 mg in 1 mL. The dose volume is 0.5 mL/dose for the Low-dose Group, 1.0 mL/dose for the Medium-dose Group, and 2.0 mL/dose for the High-dose Group.
Phosphate buffered saline of the same volume will be administered. The dose volume is 0.5 mL/dose for the Low-dose Group, 1.0 mL/dose for the Medium-dose Group, and 2.0 mL/dose for the High-dose Group.
Incidence of adverse events at week 36 [Safety and Tolerability]
The incidence of adverse events and abnormal laboratory results are recorded for safety evaluation at week 36.
Time frame: Week 36
Incidence of adverse events at week 60 [Safety and Tolerability]
The incidence of adverse events and abnormal laboratory results are recorded for safety evaluation at week 60.
Time frame: Week 60
Antigen-specific T cell responses induced by ICVAX [Immunogenicity]
Antigen-specific T cell responses induced by ICVAX are assessed at week 60 via EliSpot.
Time frame: Week 60
Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity]
Antigen-specific binding antibody responses induced by ICVAX are assessed at week 60 via ELISA.
Time frame: Week 60
The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients
The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients is evaluated at week 60 via PCR.
Time frame: Week 60
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Immuno Cure Holding (HK) Limited