ICVAX as a HIV Therapeutic DNA Vaccine

March 6, 2026 updated by: Immuno Cure Holding (HK) Limited

Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518112
        • Shenzhen Third People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Tested positive for HIV-1 infection;
  2. Aged 18-50, both male and female;
  3. Received ART treatment for ≥ 12 months with no occurrence of drug resistance during the treatment period
  4. Had <50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
  5. 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;
  6. Adopted contraception method approved by the investigator from 14 days before the first dose to at least 12 weeks after the last dose;
  7. Understands 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 in the past;
  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 event that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
  5. 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;
  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 for local application only);
  9. Infected by chronic hepatitis B virus or hepatitis C virus (HBsAg positive or HCV antibody positive)
  10. Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine>ULN, ALT or AST>1.5×ULN, hemoglobin<80g/L;
  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 population to stimulation induced by electrical pulses；Implanted with pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)
  13. Needle phobia
  14. Has contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or being receiving anticoagulation therapy
  15. The investigator considers that he/she is not suitable to participate in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-dose Group
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
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.
Experimental: Medium-dose Group
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
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.
Experimental: High-dose Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events at week 36 [Safety and Tolerability]
Time Frame: Week 36
The incidence of adverse events and abnormal laboratory results are recorded for safety evaluation at week 36.
Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events at week 60 [Safety and Tolerability]
Time Frame: Week 60
The incidence of adverse events and abnormal laboratory results are recorded for safety evaluation at week 60.
Week 60
Antigen-specific T cell responses induced by ICVAX [Immunogenicity]
Time Frame: Week 60
Antigen-specific T cell responses induced by ICVAX are assessed at week 60 via EliSpot.
Week 60
Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity]
Time Frame: Week 60
Antigen-specific binding antibody responses induced by ICVAX are assessed at week 60 via ELISA.
Week 60
The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients
Time Frame: Week 60
The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients is evaluated at week 60 via PCR.
Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immuno Cure Holding (HK) Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shenzhen Third People's Hospital
Shenzhen Immuno Cure Biomedical Company Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hui Wang, Master of Medicine, Shenzhen Third People's Hospital
  • Principal Investigator: Hongzhou Lu, Doctor of Medicine, Shenzhen Third People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YKYY-ICVAX-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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