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Study on New Strategies for Hepatitis B Virus Immunization

Not Applicable
Completed
Conditions
Vaccine Reaction
Registration Number
NCT06515938
Lead Sponsor
Wu Jiang
Brief Summary

To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.

Detailed Description

By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1169
Inclusion Criteria
  • aged 25-55 years
  • negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
Exclusion Criteria
  • a history of vaccine component allergies
  • autoimmune diseases
  • immunodeficiency
  • vaccinations received within the past month
  • acute illnesses within the past week
  • fever (axillary temperature exceeding 38°C) within the past three days

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Anti-HBsat the second month after the final injection of each arm

Titers of hepatitis B virus surface antibody

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Huaibei District Center for Disease Control and Prevention

🇨🇳

Huaibei, Anhui, China

Xuanhua District Center for Disease Control and Prevention

🇨🇳

Xuanhua, Hebei, China

Huaibei District Center for Disease Control and Prevention
🇨🇳Huaibei, Anhui, China

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