Experimental HIV vaccine shows promise in early safety trial
NCT ID NCT06253533
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a therapeutic DNA vaccine called ICVAX in 45 people with HIV who were already stable on antiretroviral therapy (ART). The goal was to see if the vaccine is safe and whether it can boost the immune system to better control the virus. Participants received different doses of the vaccine or a placebo, and researchers monitored side effects and immune responses for up to 60 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ICVAX (HIV therapeutic DNA vaccine)
- What this could lead to
- If successful, this could point toward a way to help the immune system control HIV without daily medication.
- What could go wrong
- This is a very early Phase 1 trial with only 45 people, so it is mainly checking safety. It may not show strong immune effects or lead to a functional cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
45 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shenzhen Third People's Hospital
Shenzhen, Guangdong, 518112, China
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Other studies related to the condition(s) this trial covers.
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