Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

May 23, 2013 updated by: Hui Zhuang
At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2040

Phase

  • Phase 4

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
    • Guangxi
      • Nanning, Guangxi, China
        • Guangxi Centers 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

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region

Exclusion Criteria for vaccination study:

  • acute illness
  • immunocompromised conditions
  • renal insufficiency
  • pregnancy
  • allergic history to HB vaccine or yeast
  • positive for any of HBsAg, anti-HBs or anti-HBc

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBV vaccine
HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc
Time Frame: Anti-HBs was assayed at Month 7
Anti-HBs was assayed at Month 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
Time Frame: seroprevalence at baseline
seroprevalence at baseline
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame: Anti-HBs immune response at Month 1
Anti-HBs immune response at Month 1
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame: Anti-HBs immune response at Month 6
Anti-HBs immune response at Month 6
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
Time Frame: Anti-HBs immune response at Month 20
Anti-HBs immune response at Month 20

Collaborators and Investigators

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

Sponsor

Hui Zhuang

Collaborators

Guangxi 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

September 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-HBV-001

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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