Study on New Strategies for Hepatitis B Virus Immunization

July 22, 2024 updated by: Wu Jiang

Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China

To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Study Type

Interventional

Enrollment (Actual)

1169

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 Locations

  • China
    • Anhui
      • Huaibei, Anhui, China, 235000
        • Huaibei District Center for Disease Control and Prevention
    • Hebei
      • Xuanhua, Hebei, China, 075199
        • Xuanhua District Center for Disease Control and Prevention

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged 25-55 years
  • negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination

Exclusion Criteria:

  • a history of vaccine component allergies
  • autoimmune diseases
  • immunodeficiency
  • vaccinations received within the past month
  • acute illnesses within the past week
  • fever (axillary temperature exceeding 38°C) within the past three days

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20μg Engerix-B with 0-1-6 intervals
Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals
Biological: 20μg Engerix-B hepatitis B vaccine
Experimental: 20μg Kangtai with 0-1-6 intervals
Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals
Biological: 20μg Kangtai hepatitis B vaccine
Experimental: 60μg Kangtai with 0-2 intervals
Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals
Biological: 60μg Kangtai hepatitis B vaccine
Placebo Comparator: 20μg CHO with 0-1-6 intervals
Received three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals
Biological: 20μg CHO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HBs
Time Frame: at the second month after the final injection of each arm
Titers of hepatitis B virus surface antibody
at the second month after the final injection of each arm

Collaborators and Investigators

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

Sponsor

Wu Jiang

Investigators

  • Principal Investigator: Wei Zhang, Beijing Center for Disease Control and Prevention

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)

January 1, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The original primary outcome data will be shared

IPD Sharing Time Frame

the data will become available after publication permanent

IPD Sharing Access Criteria

With consent of the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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