跳至主要内容
临床试验/NCT04970836
NCT04970836招募中不适用

The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
anti-HBs titer response rate at 7-10 days

研究概览

简要总结

This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.

详细描述

Purpose For young adults born after the neonatal hepatitis B immunization program, especially those who were 20-33 years old after 1987, additional hepatitis B vaccination may have the benefit of strengthening protection from acute hepatitis B infection among high-risk groups. However, how many doses are most appropriate for the protection of high-risk groups is still an issue to be resolved. This study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer<10 mIU/mL) need to take.

Materials and Methods From August 2021 to July 2024, the investigator will invite young adults born in Taiwan over the age of 20 and born after 1987, who have received a full course of hepatitis B vaccine at least three doses at their infant period. Those who are all negative for hepatitis B surface antibodies (anti-HBs) and surface antigens (HBsAg) are enrolled to 4 groups according to the anti-HBs titer concentration (anti-HBs titer between 2.5-10 mIU/mL is a low concentration, anti-HB titer less than 2.5 mIU/mL is an extreme low concentration) with one or two doses of hepatitis B vaccine (Engerix-B) administered, respectively. Each group recruits 60 cases to reach a total of 240 participants. Each participant was followed for 12 months, and the anti-HBs titer concentration was measured in 0, 7-10 days, 28 days, 24- 28 weeks, and 48-52 weeks. The investigator will calculate the anti-HBs titer reaction rate and immune response after receiving hepatitis B vaccine(s) at each stage, and do further univariate and multivariate analysis.

Expected Results This prospective cohort study can help understand the difference in the anti-HBs titer response after 1 or 2 revaccination doses by the anti-HBs titer concentration as well as the two different types of hepatitis B vaccination in childhood It is expected to provide an important reference for the administration of hepatitis B vaccine in young adults of high-risk groups.

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
20 Years 至 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The actual age at the time of admission was higher than 20 years old and birth year after 1987
  • Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period.
  • Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline
  • Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire
  • Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process
  • In good health

排除标准

  • Those who were previously allergic to hepatitis B vaccine or its components (such as yeast)
  • Those who have been vaccinated against hepatitis B during childhood and adolescence
  • Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen

研究组 & 干预措施

Low titer with two doses of HB Vaccines

Experimental

anti-HBs titer 2.5-10 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28

干预措施: recombinant hepatitis B vaccine (Biological)

Low titer with one dose of HB Vaccine

Active Comparator

anti-HBs titer 2.5-10 mIU/mL with one dose of HB Vaccine at Day 0

干预措施: recombinant hepatitis B vaccine (Biological)

Extremely low titer with two doses of HB Vaccines

Active Comparator

anti-HBs titer lower than 2.5 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28

干预措施: recombinant hepatitis B vaccine (Biological)

Extremely low titer with one dose of HB Vaccine

Active Comparator

anti-HBs titer lower than 2.5 mIU/mL with one dose of HB Vaccine at Day 0

干预措施: recombinant hepatitis B vaccine (Biological)

结局指标

主要结局

anti-HBs titer response rate at 7-10 days

时间窗: 7-10 days

the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)

anti-HBs titer response rate at one month

时间窗: 28 days

the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)

anti-HBs titer response rate at 6 months

时间窗: 24-28 weeks

the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)

anti-HBs titer response rate at 12 months

时间窗: 48-52 weeks

the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)

anti-HBs titer immune response change at 12 months

时间窗: 48-52 weeks

anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

The Immune Responses After Hepatitis B Revaccination... | 临床试验