NCT06184230尚未招募4 期
Open Label Study to Assess the ~32-Year Persistence of Hepatitis A Antibody Among Participants in the Pivotal, Double-Blind, Placebo-Controlled Efficacy Study of VAQTA (Study 023-001)
Best Healthcare Inc.0 个研究点目标入组 300 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Persistence of Antibody
研究概览
简要总结
The goal of this clinical trial is to evaluate the persistence of Hepatitis A antibody ~32 years post vaccination in healthy adults. The questions this study will answer are: 1) how long antibody persists and 2) The immune response to an additional dose of vaccine among those with no detectable antibody. Participants will be asked to provide a blood specimen.
Those with no detectable antibody will be offered an additional dose of vaccine.
The kinetics of antibody response in this population will be summarized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent obtained
- •Participated in original hepatitis A study in 1991
- •No detectable hepatitis A antibody ~32 years after study start
排除标准
- •Receipt of any dose of hepatitis A vaccine other than the hepatitis A vaccine used in the initial studies
- •History of hepatitis A
- •Receipt of blood transfusion or blood products, including immunoglobulins, within the past 6 months.
- •Receipt of any vaccine within the 14 days before receipt of the additional dose of hepatitis A vaccine or scheduled to receive any vaccine within 30 days after receipt of a booster dose of vaccine.
结局指标
主要结局
Persistence of Antibody
时间窗: 32 Years
Hepatitis A antibody
次要结局
未报告次要终点
研究者
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