Phase I Clinical Trial on Safety, Tolerability and Immunogenicity of HIV Therapeutic DNA Vaccine (ICVAX) in Clinically Stable HIV Patients Under ART
概览
- 阶段
- 1 期
- 干预措施
- ICVAX
- 疾病 / 适应症
- Human Immunodeficiency Virus
- 发起方
- Immuno Cure Holding (HK) Limited
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of adverse events at week 36 [Safety and Tolerability]
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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;
- •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;
研究组 & 干预措施
Low-dose Group
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.
干预措施: ICVAX
Low-dose Group
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.
干预措施: Placebo
Medium-dose Group
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.
干预措施: ICVAX
Medium-dose Group
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.
干预措施: Placebo
High-dose Group
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.
干预措施: ICVAX
High-dose Group
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.
干预措施: Placebo
结局指标
主要结局
Incidence of adverse events at week 36 [Safety and Tolerability]
时间窗: Week 36
The incidence of adverse events and abnormal laboratory results are recorded for safety evaluation at week 36.
次要结局
- Incidence of adverse events at week 60 [Safety and Tolerability](Week 60)
- Antigen-specific T cell responses induced by ICVAX [Immunogenicity](Week 60)
- Antigen-specific binding antibody responses induced by ICVAX [Immunogenicity](Week 60)
- The effect of ICVAX-ART combined treatment on the viral reservoir of HIV-infected patients(Week 60)