ICVAX as a HIV Therapeutic DNA Vaccine

NCT06253533 | Completed Phase 1 DMC

• 1 other identifier: YKYY-ICVAX-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus; Human Immunodeficiency Virus I Infection

Keywords

ICVAX; HIV; AIDS; DNA Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 36

Secondary Outcomes (4)

• Incidence of adverse events at week 60 [Safety and Tolerability]

  Week 60

• Antigen-specific T cell responses induced by ICVAX [Immunogenicity]

  Week 60

• Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity]

  Week 60

• The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients

  Week 60

Study Arms (3)

Low-dose Group

EXPERIMENTAL

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

Medium-dose Group

EXPERIMENTAL

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

High-dose Group

EXPERIMENTAL

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

Interventions

ICVAX BIOLOGICAL

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.

High-dose Group; Low-dose Group; Medium-dose Group

Placebo OTHER

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.

High-dose Group; Low-dose Group; Medium-dose Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Tested positive for HIV-1 infection;
• Aged 18-50, both male and female;
• Received ART treatment for ≥ 12 months with no occurrence of drug resistance during the 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 at the beginning of ART;
• Adopted contraception method approved by the investigator from 14 days before the first dose to at least 12 weeks after the last dose;
• Understands 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 in the past;
• 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 event that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
• Has a history of autoimmune diseases; a history of severe allergies, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially those who have hypersensitivity to the drug components of this study;
• 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 for local application only);
• Infected by chronic hepatitis B virus or hepatitis C virus (HBsAg positive or HCV antibody positive)
• Has any abnormal laboratory results including: neutrophil \<1×109/L, serum creatinine\>ULN, ALT or AST\>1.5×ULN, hemoglobin\<80g/L;
• Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
• Sensitive population to stimulation induced by electrical pulses；Implanted with pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)
• Needle phobia
• Has contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or being receiving anticoagulation therapy
• The investigator considers that he/she is not suitable to participate in this trial.

Sponsors & Collaborators

• Immuno Cure Holding (HK) Limited: lead
• Shenzhen Third People's Hospital: collaborator
• Shenzhen Immuno Cure Biomedical Company Limited: collaborator

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518112, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hui Wang, Master of Medicine

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Hongzhou Lu, Doctor of Medicine

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: February 14, 2023
• Primary Completion: September 30, 2024
• Study Completion: August 7, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)