NCT00349141已完成1 期
A Phase I/II Dose Escalation Study of a Vero Cell-Derived, Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 6
研究概览
简要总结
The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and femal subjects who
- •are 18 to 45 years of age, inclusive, on the day of screening;
- •have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
- •are clinically healthy, as determined by medical history and physical examination;
- •agree to keep a daily record of symptoms;
- •if female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.
排除标准
- •Subjects who
- •are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
- •suffer from a significant neurological, cardiac, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological or renal disorder;
- •are unable to lead an independent life as a result of either physical or mental handicap;
- •suffer from any kind of immunodeficiency;
- •suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
- •have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré);
- •have a history of severe allergic reactions or anaphylaxis;
- •have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
- •have received a blood transfusion or immunoglobulins within 90 days of study entry;
- •have donated blood or plasma within 30 days of study entry;
- •have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
- •have undergone systemic corticoid therapy within 30 days prior to study entry;
- •have a functional or surgical asplenia;
- •have a known or suspected problem with alcohol or drug abuse;
- •were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
- •are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator;
- •if female, are pregnant or lactating.
研究者
研究点 (6)
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