NCT01341275Unknown4 期
Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood
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:
- the degree of immunity against hepatitis B,
- factors associated with immunity against hepatitis B,
- 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
- 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
- 否
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
研究点 (4)
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