NCT00354861已完成1 期
A Phase I, Single-Blind Study to Determine the Safety, Tolerability and Pharmacodynamic Profiles of a Hepatitis B Antigen Combined With IMP321 Versus the Hepatitis B Antigen Alone and a Reference Vaccine in Healthy Young Male Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- To evaluate clinical and laboratory safety and tolerability profiles
研究概览
简要总结
This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized study.
详细描述
In each cohort, 8 subjects will receive the hepatitis B antigen (10 µg) with IMP321 at one dose, 2 subjects will receive the reference hepatitis B antigen (10 µg) alone with physiological saline and 2 subjects will receive the commercial vaccine Engerix B® (20 µg).
Engerix B® will be administered intramuscularly. The other treatments will be administered subcutaneously.
The four successive cohorts of volunteers will be:
Cohort A:
- 8 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 (3 µg),
- 2 subjects treated by hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline,
- 2 subjects treated by the commercial hepatitis vaccine Engerix B® (20 µg HBsAg with alum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to give a written informed consent ;
- •healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years;
- •with body mass index (weight/height²) in the range 18 to 30 kg/m²;
- •registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12.88) on biomedical experimentation;
- •able to comply with protocol requirements, including overnight stays, blood and urine sample collections as defined in the protocol;
- •not previously vaccinated for Hepatitis B.
排除标准
- •who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected HIV, HBV and HCV infection ;
- •with any clinically significant abnormality following review of pre-study laboratory tests and full physical examination ;
- •who have received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health ;
- •who forfeit their freedom by administrative or legal award or who were under guardianship ;
- •unwilling to give their informed consent ;
- •who present a positive laboratory test for Hepatitis B surface antigen (HbsAg), HBc antibodies, HIV 1 and 2 antibodies and HCV antibodies ;
- •who have a history of allergy or intolerance to the study drug ;
- •who had a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug ;
- •who are known or suspected alcohol or drug abusers ;
- •who present a positive laboratory test for urine drug screening (opiates, barbiturates, amphetamine, cannabis) ;
- •who undergo surgery or have donated blood within 1 month prior to the start of the study ;
- •who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 1 week prior to the first dose administration ;
- •who receive any drug known to affect hepatic metabolism like cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin within 1 month prior to the first dose administration ;
- •who receive any drug known to affect renal tubular secretion like probenecid, beta-lactam antibiotics within 2 weeks prior to the first dose administration ;
- •who present any clinical condition or prior therapy which, in the opinion of the investigator, made the subject unsuitable for the study.
结局指标
主要结局
To evaluate clinical and laboratory safety and tolerability profiles
时间窗: 3 months
次要结局
- To determine T cell response induction efficacy(3 months)
研究者
研究点 (2)
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