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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04970836
Other study ID # 202012221MINB
Secondary ID 110-2314-B-002-1
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date December 31, 2024

Study information

Verified date June 2022
Source National Taiwan University Hospital
Contact CHYI-FENG JAN, MD, PHD
Phone +886-2-23123456
Email jcf036@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
recombinant 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

Country Name City State
Taiwan Family Medicine, NTUH Taipei

Sponsors (3)

Lead Sponsor Collaborator
National Taiwan University Hospital Academia Sinica, Taiwan, Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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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