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

Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861613
• Other study ID #: PRO-HBV-001
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2013
• Last updated: May 23, 2013
• Start date: September 2009

Study information

• Verified date: May 2013
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2040
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 30 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Immune Response
• Seroprevalence

Intervention

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

Locations

Country	Name	City	State
China	Guangxi Centers for Disease Control and Prevention	Nanning	Guangxi

Sponsors (2)

Lead Sponsor	Collaborator
Hui Zhuang	Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc		Anti-HBs was assayed at Month 7	No
Secondary	Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students		seroprevalence at baseline	No
Secondary	Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc		Anti-HBs immune response at Month 1	No
Secondary	Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc		Anti-HBs immune response at Month 6	No
Secondary	Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc		Anti-HBs immune response at Month 20	No