NCT02390466Unknown1 期
Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1
InnaVirVax4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •HIV-1 infected patient,
- •Age between 18 and 60 years,
- •ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
- •Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
- •Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
- •CD4+ T cell count ≥ 200 cells/mm3,
- •Nadir CD4+ T cell count ≥ 100 cells/mm3,
- •Contraception in women with child-bearing potential,
- •A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
- •Per protocol subject having completed the IVVAC-3S/P1 study.
- •Patient affiliated to a social security system,
- •Patient who has understood the protocol design and provided a signed written informed consent form,
- •Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
- •Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.
排除标准
- •Administration of VAC-3S in the past year,
- •Chronic active liver disease,
- •History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
- •Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
- •Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
- •Ongoing pregnancy,
- •Breastfeeding women,
- •Patient with known sensitivities to investigational drug (see please the CIB),
- •History of allergy to any vaccine,
- •Any severe chronic condition that would interfere with the study,
- •History of auto-immune disease,
- •Organ transplant,
- •Splenectomy,
- •Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
- •Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
- •Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
- •Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
结局指标
主要结局
Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.
时间窗: From Day 0 to week 16
次要结局
- Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.(From Week 16 to Week 48)
- Anti-3S antibody titers(From Day 0 to Week 48)
- Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation(From Day 0 to Week 48)
研究者
研究点 (4)
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