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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04970836

Collaborator

Academia Sinica, Taiwan (Other), Ministry of Science and Technology, Taiwan (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Vaccination; Infection Preventable Disease, Vaccine	Biological: recombinant hepatitis B vaccine	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective cohort studyprospective cohort study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low titer with two doses of HB Vaccines anti-HBs titer 2.5-10 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28	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. Other Names: Engerix-B
Active Comparator: Low titer with one dose of HB Vaccine anti-HBs titer 2.5-10 mIU/mL with one dose of HB Vaccine at Day 0	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. Other Names: Engerix-B
Active Comparator: Extremely low titer with two doses of HB Vaccines anti-HBs titer lower than 2.5 mIU/mL with two doses of HB Vaccines at Day 0 and Day 28	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. Other Names: Engerix-B
Active Comparator: Extremely low titer with one dose of HB Vaccine anti-HBs titer lower than 2.5 mIU/mL with one dose of HB Vaccine at Day 0	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. Other Names: Engerix-B

Outcome Measures

Primary Outcome Measures

anti-HBs titer response rate at 7-10 days [7-10 days]
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at one month [28 days]
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at 6 months [24-28 weeks]
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer response rate at 12 months [48-52 weeks]
the anti-HBs titer response rate after 1-2 doses of hepatitis B vaccine(s)
anti-HBs titer immune response change at 12 months [48-52 weeks]
anti-HBs titer immune response change at 12 months after 1-2 doses of hepatitis B vaccine(s)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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