Hepatitis B Clinical Trial
— IRHBRVDOfficial title:
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 36 Years |
Eligibility | Inclusion Criteria: 1. The actual age at the time of admission was higher than 20 years old and birth year after 1987 2. Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period. 3. Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline 4. Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire 5. Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process 6. In good health Exclusion Criteria: 1. Those who were previously allergic to hepatitis B vaccine or its components (such as yeast) 2. Those who have been vaccinated against hepatitis B during childhood and adolescence 3. Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen |
Country | Name | City | State |
---|---|---|---|
Taiwan | Family Medicine, NTUH | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Academia Sinica, Taiwan, Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anti-HBs titer response rate at 7-10 days | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 7-10 days | |
Primary | anti-HBs titer response rate at one month | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 28 days | |
Primary | anti-HBs titer response rate at 6 months | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 24-28 weeks | |
Primary | anti-HBs titer response rate at 12 months | the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s) | 48-52 weeks | |
Primary | 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) | 48-52 weeks |
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