An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-028 (208127/021) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)
研究概览
简要总结
This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline (GSK) Biologicals' Twinrix Adult. The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit.
No new subjects will be recruited during this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
- •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 who received the complete primary vaccination course in the primary study Hepatitis A and B vaccine (HAB), HAB-028 (208127/021).
- •Written informed consent obtained from the subject.
- •All subjects must satisfy the following criteria at entry into the challenge dose phase:
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •A male or female who received the complete primary vaccination course in the primary study HAB-028 (208127/021).
- •Written informed consent obtained from the subject.
- •Subjects who participated in the long-term follow-up (LTFU) phase of the HAB-028 (208127/021) study and for whom the antibody concentrations were below the cut-off at the last available follow-up time-point.
- •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 vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception for two months after the administration of the challenge dose.
排除标准
- •The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
- •Use of any investigational or non-registered product within 30 days prior to blood sampling.
- •Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study HAB-028 (208127/021).
- •History of hepatitis A or hepatitis B infection since the primary study HAB-028 (208127/021).
- •Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.
- •The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:
- •Use of any investigational or non-registered product within 30 days prior to study start or planned use during the study.
- •Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit.
- •History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit.
- •History of anaphylactic reactions following the administration of vaccines.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Acute disease and/or fever at the time of enrolment.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
研究组 & 干预措施
Twinrix Group
Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
干预措施: Blood sampling (Procedure)
Twinrix Group
Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
干预措施: Havrix (Biological)
Twinrix Group
Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
干预措施: Engerix-B (Biological)
结局指标
主要结局
Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)
时间窗: At Years 16, 17, 18, 19 and 20.
Seropositivity for anti-HAV antibodies is defined as antibody concentrations \>= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations \>= 6.2 mIU/mL.
Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)
时间窗: At Years 16, 17, 18, 19 and 20.
Concentrations were expressed as GMCs in mIU/mL.
次要结局
- Number of Subjects With Immune Response to the Challenge Vaccine Antigen(Before, 14 days and one month after the challenge dose at Year 19.)
- Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration(At Year 18, 14 days and 30 days post challenge dose (Year 19).)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Up to Year 20.)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.)