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

June 24, 2022 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CHYI-FENG JAN, MD, PHD
  • Phone Number: 66824 +886-2-23123456
  • Email: jcf036@gmail.com

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Family Medicine, NTUH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Ministry of Science and Technology, Taiwan
Academia Sinica, Taiwan

Investigators

  • Principal Investigator: CHYI-FENG JAN, MD, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202012221MINB
  • 110-2314-B-002-132 (Other Grant/Funding Number: The Ministry of Science and Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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