Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06253533
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06253533
Study Brief:
Protocol Section:
NCT06253533