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ICVAX as a HIV Therapeutic DNA Vaccine

NCT06253533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-10

No results posted yet for this study

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

Interventions

BIOLOGICAL

ICVAX

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • Shenzhen Immuno Cure Biomedical Company Limited

    collaborator INDUSTRY

  • Immuno Cure Holding (HK) Limited

    lead INDUSTRY

Principal Investigators

  • Hui Wang, Master of Medicine · Shenzhen Third People's Hospital

  • Hongzhou Lu, Doctor of Medicine · Shenzhen Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2024-09-30
Completion
2025-08-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06253533 on ClinicalTrials.gov