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

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ClinicalTrials.gov Identifier: NCT01861613
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 24, 2013
Sponsor:
Collaborator:
Guangxi Center for Disease Control and Prevention
Information provided by (Responsible Party):
Hui Zhuang, Peking University

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
Hepatitis B Immune Response Seroprevalence Biological: HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2040 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2009
Actual Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine


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)



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

Secondary Outcome Measures :
  1. Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students [ Time Frame: seroprevalence at baseline ]
  2. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [ Time Frame: Anti-HBs immune response at Month 1 ]
  3. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [ Time Frame: Anti-HBs immune response at Month 6 ]
  4. Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc [ Time Frame: Anti-HBs immune response at Month 20 ]


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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861613


Locations
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China, Guangxi
Guangxi Centers for Disease Control and Prevention
Nanning, Guangxi, China
Sponsors and Collaborators
Hui Zhuang
Guangxi Center for Disease Control and Prevention

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Responsible Party: Hui Zhuang, Professor, Peking University
ClinicalTrials.gov Identifier: NCT01861613     History of Changes
Other Study ID Numbers: PRO-HBV-001
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs