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临床试验/NCT01341275
NCT01341275Unknown4 期

Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood

Baylor College of Medicine4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
4 期
入组人数
400
试验地点
4
主要终点
anti-HBSAg titers

研究概览

简要总结

The aims of this study are to determine:

  1. the degree of immunity against hepatitis B,
  2. factors associated with immunity against hepatitis B,
  3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and
  4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.

Study subjects eligible for enrollment will:

  • have blood drawn for baseline serologies
  • receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)
  • have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)

The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.

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
None

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 16-19 years of age
  • born in the United States
  • received the full hepatitis B vaccination series by 12 months of age
  • received the third dose of hepatitis B vaccine within 10 months of the first dose

排除标准

  • a history of hepatitis B disease
  • being born to a mother with hepatitis B at the time of the participant's birth
  • having received hepatitis B immune globulin as an infant
  • immunosuppression including HIV or chronic/current steroid use (use > 10 days duration within the 3 months of enrollment)
  • renal insufficiency or dialysis
  • pregnancy (due to theoretical risk of different immune response among pregnant females)
  • ever receiving a booster (fourth) dose of hepatitis B vaccine
  • history of allergy to the hepatitis B vaccine
  • receipt of blood products or IgG within 3 months of enrollment
  • having received another vaccine within 2 weeks of enrollment

结局指标

主要结局

anti-HBSAg titers

时间窗: 13-15 days after enrollment and booster dose

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (4)

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