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

Hui Zhuang

Status and phase: Completed; Phase 4

Conditions: Immune Response; Seroprevalence; Hepatitis B

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01861613

PRO-HBV-001

Details and patient eligibility

About

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.

Enrollment: 2,040 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,040 participants in 1 patient group

HBV vaccine

Experimental group

Description:

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

Treatment:

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