NCT00657657已完成4 期
Immune Response to a Hepatitis B Vaccine Challenge Dose in Healthy Subjects Who Received Primary Vaccination of GlaxoSmithKline Biologicals' Hepatitis B Vaccine, Approximately 20 Years Ago.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine
研究概览
简要总结
In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via assessment of the response to a vaccine challenge dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 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 should be enrolled in the study.
- •A male or female adult who received the complete neonatal primary vaccination course of hepatitis B vaccine (Engerix™-B), in the 103860/272 primary study approximately 20 years earlier.
- •Documented level of anti-HBs antibody concentrations < 100 milli-international units per milliliter (mIU/ml) at the previous long-term time-point for which serological results are available for that subject.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the hepatitis B challenge dose.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
- •Subjects who received a booster dose of hepatitis B vaccine outside the context of this study between the long-term time-point at the documented level of anti-HBs antibody concentrations and the current challenge dose study visit.
- •Concurrently participating in another clinical study, 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.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
结局指标
主要结局
Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine
时间窗: One month after the hepatitis B vaccine challenge dose
Immune response to a challenge dose of hepatitis B vaccine is defined as * at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or * a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (\<3.3 mIU/mL) at the previous available long-term time point.
次要结局
- Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values(One month after the hepatitis B vaccine challenge dose)
- Concentration of Anti-HBs Antibodies(One month after the hepatitis B vaccine challenge dose)
- Number of Subjects Reporting Unsolicited Adverse Events(During the 31-day follow-up period after the challenge dose of hepatitis B vaccine)
- Number of Subjects Reporting Serious Adverse Events(During the 31-day follow-up period after the challenge dose of hepatitis B vaccine)
研究者
研究点 (2)
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