Sustaining Protection Against Hepatitis B From Infancy to Adulthood: Assessing the Case for a Booster Dose in Adolescence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 2
- 主要终点
- Serum Anti-HBs Concentration 12 IU/L or Greater
研究概览
简要总结
This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B disease. Adolescents will be invited to have a blood test and those without a minimal level of protection (antibody titer) will be offered a "test" vaccination to see if they still have capacity to recall an immune response. About one month later they will get another blood test to see if a booster response occurred. A few participants will have lost protection (no booster response) and will be offered a second HB vaccination to restore protection. Results of this study could influence the way in which children in British Columbia (BC) are immunized against HB disease.
详细描述
Purpose:
The purpose of the study is to assess whether or not individuals immunized as infants with Hepatitis B vaccine have residual immunity in their pre-adolescent and adolescent years. Two age groups (10, 11 year olds and 15, 16 year olds) will be invited to have blood taken to measure their level of protection (antibody titer). Those without a minimum protective titer will be offered a Hepatitis B "test" vaccination to determine if they still have the capacity to recall an immune response (ie immune memory), as a second line of protection against infection. A second blood sample will be obtained to determine if a booster response occurred (immune memory persists, protection intact) or not. The study vaccine will be a pediatric dose of HB vaccine (EngerixB) made by GlaxoSmithKline Canada (10mcg), a licensed product used in the public immunization program in British Columbia (BC) currently.
Hypothesis:
The hypothesis being tested is that protection has been lost in a sufficient proportion of 15-16 year olds to warrant consideration of a pre-adolescent HB booster, modeled by the 10-11 year olds whose protection is expected to be uniformly reinforceable.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10-11 or 15-16 years
- •Written informed assent provided by 10-11 year old participants and consent by their parent or legal guardian OR written informed consent provided by a 15-16 year old participant.
- •Subjects whom the investigator believes can and will comply with the requirements of the protocol.
- •General good health
- •Immunized in BC on the regular schedule with hepatitis B vaccine at approximately 2, 4, 6 months of age, based on an available immunization record.
排除标准
- •Hepatitis B vaccination regimen for infants born to a mother with hepatitis B infection (e.g. doses at birth and ages 1 and 6 months, with or without HB immune globulin at birth).
- •Receipt of any additional dose(s) of hepatitis B vaccine beyond infancy.
- •Systemic hypersensitivity to hepatitis B vaccine or severe reaction to any previous dose of hepatitis B vaccine.
- •Receipt of blood or blood product within 3 months prior to Visit
- •Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit
- •Chronic health condition requiring ongoing medical supervision e.g. cystic fibrosis.
- •Incapacity to provide fully informed assent, resulting from cognitive impairment.
- •Inadequate participant or parental (when the parent will provide consent) fluency in English to provide fully informed consent.
结局指标
主要结局
Serum Anti-HBs Concentration 12 IU/L or Greater
时间窗: 10 or more years after infant HB immunization
The primary outcome measure is the number of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer \>12 IU/L.
Recollection of Anti-HBs Titer >12 IU/L After Booster
时间窗: 28 days after HB booster
The primary outcome measure is the number of participants who have capacity to recall anti-HBs titer \>12 IU/L after HB booster vaccination.
次要结局
未报告次要终点
研究者
David Scheifele
Clinical Professor
University of British Columbia