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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Hepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups. Each case will be tracked for 12 months, at 0, 7-10 days, 28 days, 24-28 weeks, 48-52 weeks anti-HBs titer concentration and 4 follow-up questionnaires.
Family Medicine, NTUH
Taipei, Taiwan
RECRUITINGanti-HBs titer response rate at 7-10 days
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame: 7-10 days
anti-HBs titer response rate at one month
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame: 28 days
anti-HBs titer response rate at 6 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame: 24-28 weeks
anti-HBs titer response rate at 12 months
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
Time frame: 48-52 weeks
anti-HBs titer immune response change at 12 months
anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s)
Time frame: 48-52 weeks
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