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

Sponsor
Hui Zhuang (Other)
Overall Status
Completed
CT.gov ID
NCT01861613
Collaborator
Guangxi Center for Disease Control and Prevention (Other)
2,040
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2040 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2011

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc [Anti-HBs was assayed at Month 7]

Secondary Outcome Measures

  1. Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students [seroprevalence at baseline]

  2. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [Anti-HBs immune response at Month 1]

  3. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [Anti-HBs immune response at Month 6]

  4. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [Anti-HBs immune response at Month 20]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangxi Centers for Disease Control and Prevention Nanning Guangxi China

Sponsors and Collaborators

  • Hui Zhuang
  • Guangxi Center for Disease Control and Prevention

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui Zhuang, Professor, Peking University
ClinicalTrials.gov Identifier:
NCT01861613
Other Study ID Numbers:
  • PRO-HBV-001
First Posted:
May 23, 2013
Last Update Posted:
May 24, 2013
Last Verified:
May 1, 2013
Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis

Study Results

No Results Posted as of May 24, 2013