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Completed

NCT Number: NCT01861613

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Immune Response Infections Liver Diseases Seroprevalence Virus Diseases

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangxi Centers for Disease Control and Prevention

Nanning, Guangxi, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)

Biological

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hui Zhuang

Other

Collaborators

  • Guangxi Center for Disease Control and Prevention

Registry information

Important dates

Study start
2009
Primary completion
2011
First posted
May 23, 2013
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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