NCT01099488已完成不适用
A Study in Healthy Adults Having Received a Single Vaccine Administration to Support the Development of Immunological Assays
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Frequency of CD8+ T-cells at protocol-defined time points.
研究概览
简要总结
The purpose of this study is to develop immunological assays on blood samples.
详细描述
This is a clinical study in which there is no vaccine administered. It is designed for research purposes such as developing immunological assays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
- •A male or female between, and including, 18 and 50 years of age at study start.
- •A subject having received a Yellow Fever (YF) vaccine on the day of study entry.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination performed on the day of YF vaccination.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to study start, and
- •has agreed to continue adequate contraception during the entire study period.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding study start, or planned use during the study period.
- •Concurrently participating in another clinical study, within 3 months preceding study start and at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Clinically significant anaemia or any known condition as per medical history that would preclude the drawing of blood as described in the protocol.
- •Known previous infection with YF virus.
- •Previous vaccination against YF more than approximately 5 hours before the blood sampling at Visit
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study start or planned administration during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs (including chloroquine) within six months prior to the study start. For corticosteroids, this will mean prednisone ≥ 10mg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Receipt of live attenuated vaccines other than the YF vaccine during the period beginning 30 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit
- •Receipt of inactivated influenza vaccines (seasonal or pandemic) during the period beginning 21 days preceding the blood sampling at Visit 1 or planned use during the study up to the blood sampling at Visit
- •History of malignancy (unless there has been surgical excision followed by a sufficient observation period, of at least 5 years, to give a reasonable assurance of sustained cure and which, in the estimate of the investigator, is not likely to recur during the study period).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV, hepatitis B and hepatitis C), based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and medical history.
- •Acute disease and/or fever at the time of enrolment.
- •Known pregnant or lactating female, as per medical records.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •History of chronic alcohol consumption and/or drug abuse.
- •Any condition that may preclude the compliance to the study protocol.
结局指标
主要结局
Frequency of CD8+ T-cells at protocol-defined time points.
时间窗: At Day 0, Day 14 and Day 180.
次要结局
- Frequency of CD4+ T-cells response at protocol-defined time points.(At Day 0, Day 14 and Day 180.)
研究者
研究点 (3)
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