HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong: Evaluation of Immunogenicity and Safety of ICVAX in ART-treated Clinically Stable HIV-infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety of ICVAX
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the safety and immunogenicity of the HIV Therapeutic DNA Vaccine (ICVAX) in participants with HIV-1 infection under antiretroviral therapy (ART). The study compares three delivery methods - Teresa -EPT I, PharmaJet Tropis, and PapiVax TriGrid EP - to induce antigen-specific T cell responses in the participants.
The primary objectives are to evaluate the safety of ICVAX delivered using three different devices in the participants within the period Day 0-Day 336, and to evaluate the antigen-specific T cell responses induced by ICVAX in the participants within the period Day 0-Day 168.
The participants will receive four injections of ICVAX administered at 4-week intervals. Following the final dose, participants will be monitored for 36 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tested positive for HIV-1 antibody;
- •Aged 18-60, both male and female;
- •BMI (body mass index) in between 18.5 and 24.9 kg/m2 (including upper and lower limits);
- •Received ART for ≥12 months; no drug resistance occurred during this 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 before initiation of ART;
- •Adopted contraception method approved by the investigator from screening period until the end of study;
- •Understand 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 continuously since ART initiation;
- •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 events that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
- •Has a history of autoimmune diseases; Has hypersensitivity to the components of this drug including ICVAX recombinant plasmid, NaCl, Na2HPO4 and NaH2PO4·H2O, and shows severe allergies, such as dyspnea, edema and other symptoms after administration;
- •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 local application);
- •Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;
- •Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine > ULN, ALT or AST >1.5×ULN, hemoglobin < 11g/dL;
- •Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
- •Sensitive to electrical pulse stimulation, such as those who are implanted with pacemaker/ Automatic Implantable Cardioverter Defibrillator (AICD), or those who have wearable medical electronic devices including electrocardiogram;
- •Needle phobia;
- •Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;
- •The investigator considers that he/she is not suitable to participate in this trial.
研究组 & 干预措施
Arm 1: ICVAX administration via TERESA-EPT I device
Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TERESA-EPT I device.
干预措施: ICVAX (TERESA-EPT I device) (Biological)
Arm 2: ICVAX administration via PharmaJet Tropis device
Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the PharmaJet Tropis device.
干预措施: ICVAX (PharmaJet Tropis device) (Biological)
Arm 3: ICVAX administration via TriGrid device
Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TriGrid device.
干预措施: ICVAX (TriGrid device) (Biological)
结局指标
主要结局
Safety of ICVAX
时间窗: Day 0-Day 336
To evaluate the incidence of adverse events and abnormal laboratory results within the period Day 0-Day 336.
Antigen-specific T Cell Response Induced by ICVAX
时间窗: Day 0-Day 168
To evaluate the antigen-specific T cell responses induced by ICVAX within the period Day 0-Day 168 via ELISpot.
次要结局
- Humoral Immune Response of ICVAX(Day 0-Day 336)
- Effect of ICVAX-ART Combined Treatment on Viral Reservoir(Day 0-Day 336)