Human Immunodeficiency Virus Clinical Trial
Official title:
Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART
Verified date | February 2024 |
Source | Immuno Cure Holding (HK) Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 45 |
Est. completion date | January 7, 2025 |
Est. primary completion date | June 22, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Third People's Hospital | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Immuno Cure Biomedical Company Limited | Shenzhen Third People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 36 | |
Secondary | 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. | Week 60 | |
Secondary | Antigen-specific T cell responses induced by ICVAX [Immunogenicity] | Antigen-specific T cell responses induced by ICVAX are assessed at week 60 via EliSpot. | Week 60 | |
Secondary | Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity] | Antigen-specific binding antibody responses induced by ICVAX are assessed at week 60 via ELISA. | Week 60 | |
Secondary | 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. | Week 60 |
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