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

Phase 4

Completed

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

• Registration Number: NCT01861613
• Lead Sponsor: Hui Zhuang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-11
• Status Verified: 2013-05
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2040

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students	seroprevalence at baseline
Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc	Anti-HBs immune response at Month 20

Trial Locations

Locations (1)

Guangxi Centers for Disease Control and Prevention; 🇨🇳 Nanning, Guangxi, China