Clinical trial NCT06253533: ICVAX as a HIV Therapeutic DNA Vaccine
Official title: Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Human Immunodeficiency Virus
Human Immunodeficiency Virus I Infection
Keywords: ICVAX
HIV
AIDS
DNA Vaccine
Lead sponsor: Immuno Cure Holding (HK) Limited
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen Third People's Hospital
name: Shenzhen Immuno Cure Biomedical Company Limited
First posted: 2024-02-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Incidence of adverse events at week 36 [Safety and Tolerability]
timeFrame: Week 36
Secondary outcomes:
measure: Incidence of adverse events at week 60 [Safety and Tolerability]
timeFrame: Week 60
measure: Antigen-specific T cell responses induced by ICVAX [Immunogenicity]
timeFrame: Week 60
measure: Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity]
timeFrame: Week 60
measure: The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients
timeFrame: Week 60
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Third People's Hospital
name: Hui Wang, Master of Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Third People's Hospital
name: Hongzhou Lu, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References: