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

NCT ID: NCT04970836

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Hepatitis B; Vaccination; Infection; Preventable Disease, Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

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.

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

Group Type: ACTIVE_COMPARATOR

recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

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.

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

Group Type: ACTIVE_COMPARATOR

recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

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.

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

Group Type: ACTIVE_COMPARATOR

recombinant hepatitis B vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Engerix-B

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academia Sinica, Taiwan

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CHYI-FENG JAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Family Medicine, NTUH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

CHYI-FENG JAN, MD, PHD

Role: CONTACT

jcf036@gmail.com

+886-2-23123456 ext. 66824

Facility Contacts

CHYI-FENG JAN, MD, PhD

Role: primary

jcf036@ntuh.gov.tw

+886-2-23123456 ext. 66824

Other Identifiers

110-2314-B-002-132

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202012221MINB

Identifier Type: -

Identifier Source: org_study_id