RecruitingNot Applicable

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

Taiwan240 participantsStarted 2021-08-01

Plain-language 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.

Who can participate

Age range20 Years – 36 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

anti-HBs titer response rate at 7-10 days

Timeframe: 7-10 days

anti-HBs titer response rate at one month

Timeframe: 28 days

anti-HBs titer response rate at 6 months

Timeframe: 24-28 weeks

anti-HBs titer response rate at 12 months

Timeframe: 48-52 weeks

anti-HBs titer immune response change at 12 months

Timeframe: 48-52 weeks

Trial details

NCT IDNCT04970836

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

CHYI-FENG JAN, MD, PHD

+886-2-23123456 jcf036@gmail.com

View on ClinicalTrials.gov More Hepatitis B trials

Who can participate

Age range20 Years – 36 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

anti-HBs titer response rate at 7-10 days

Timeframe: 7-10 days

anti-HBs titer response rate at one month

Timeframe: 28 days

anti-HBs titer response rate at 6 months

Timeframe: 24-28 weeks

anti-HBs titer response rate at 12 months

Timeframe: 48-52 weeks

anti-HBs titer immune response change at 12 months

Timeframe: 48-52 weeks