RecruitingNot ApplicableNCT04970836

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


Sponsor

National Taiwan University Hospital

Enrollment

240 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 36 Years

Inclusion Criteria6

  • 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

Exclusion Criteria3

  • 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

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Interventions

BIOLOGICALrecombinant hepatitis B vaccine

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.


Locations(1)

Family Medicine, NTUH

Taipei, Taiwan

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NCT04970836


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