NCT04970836

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Aug 2021Dec 2027

First Submitted

Initial submission to the registry

July 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6.4 years

First QC Date

July 6, 2021

Last Update Submit

March 17, 2025

Conditions

Hepatitis BVaccination; InfectionPreventable Disease, Vaccine

Keywords

hepatitis B vaccinerevaccinationyoung adultbooster

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

Low titer with two doses of HB Vaccines

EXPERIMENTAL

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

Low titer with one dose of HB Vaccine

ACTIVE COMPARATOR

anti-HBs titer 2.5-10 mIU/mL with one dose of HB Vaccine at Day 0

Biological: recombinant hepatitis B vaccine

Extremely low titer with two doses of HB Vaccines

ACTIVE COMPARATOR

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

Extremely low titer with one dose of HB Vaccine

ACTIVE COMPARATOR

anti-HBs titer lower than 2.5 mIU/mL with one dose of HB Vaccine at Day 0

Biological: recombinant hepatitis B vaccine

Interventions

recombinant hepatitis B vaccineBIOLOGICAL

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.

Also known as: Engerix-B
Extremely low titer with one dose of HB VaccineExtremely low titer with two doses of HB VaccinesLow titer with one dose of HB VaccineLow titer with two doses of HB Vaccines

Eligibility Criteria

Age20 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine, NTUH

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis BInfectionsVaccine-Preventable Diseases

Interventions

Hepatitis B VaccinesEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • CHYI-FENG JAN, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHYI-FENG JAN, MD, PHD

CONTACT

+886-2-23123456jcf036@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 21, 2021

Study Start

August 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)