Human Immunodeficiency VirusPhase 1NCT06253533

ICVAX as a HIV Therapeutic DNA Vaccine

A Phase 1 study testing ICVAX in people with Human Immunodeficiency Virus and Human Immunodeficiency Virus I Infection, run by Immuno Cure Holding (HK) Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
What is being tested?: ICVAX
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteChina
Study dates: 14 Feb 2023to 7 Aug 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shenzhen Third People's Hospital
Shenzhen, Guangdong, 518112

Other trials in China

About this study

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

Read the 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.

Conditions: Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
Being tested: ICVAX, Placebo
Keywords: ICVAX, HIV, AIDS, DNA Vaccine
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICVAXBiological
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.
PlaceboOther
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.

Study groups in NCT06253533
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Biological: ICVAX; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 36

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20237 Aug 2025

First posted12 Feb 2024
Study start14 Feb 2023
Primary completion30 Sep 2024
Study completion7 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06253533
Sponsor's protocol ID: YKYY-ICVAX-101
Status last verified: Mar 2026
First submitted: 25 Jan 2024
Last updated: 10 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART
ClinicalTrials.gov ID: NCT06253533
Acronym / sponsor ID: YKYY-ICVAX-101
Conditions: Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection
Keywords: ICVAX, HIV, AIDS, DNA Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Immuno Cure Holding (HK) LimitedIndustry (pharma, biotech, devices)
Collaborators: Shenzhen Third People's Hospital, Shenzhen Immuno Cure Biomedical Company Limited
Study start: 14 Feb 2023 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: 7 Aug 2025 (actual)
First posted: 12 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low-dose Group	Experimental	Biological: ICVAX, Other: PlaceboClinically 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.
Medium-dose Group	Experimental	Biological: ICVAX, Other: PlaceboClinically 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.
High-dose Group	Experimental	Biological: ICVAX, Other: PlaceboClinically 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICVAXICVAX 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.	Biological	High-dose Group, Low-dose Group, Medium-dose Group
PlaceboPhosphate 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.	Other	High-dose Group, Low-dose Group, Medium-dose Group

Primary outcome

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.

4 secondary outcomes

Incidence of adverse events at week 60 [Safety and Tolerability]
Time frame: Week 60
Antigen-specific T cell responses induced by ICVAX [Immunogenicity]
Time frame: Week 60
Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity]
Time frame: Week 60
The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients
Time frame: Week 60

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Individual participant dataSharing planned: 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.

Related trials for Human Immunodeficiency Virus

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Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hui Wang, Master of Medicine principal investigator

Shenzhen Third People's Hospital

Hongzhou Lu, Doctor of Medicine principal investigator

Shenzhen Third People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ICVAX in people with Human Immunodeficiency Virus and Human Immunodeficiency Virus I Infection, run by Immuno Cure Holding (HK) Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events at week 36 [Safety and Tolerability] (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.