Study on New Strategies for Hepatitis B Virus Immunization

Not Applicable

Completed

• Conditions: Vaccine Reaction
• Interventions: Biological: 20μg Engerix-B hepatitis B vaccine; Biological: 20μg CHO; Biological: 20μg Kangtai hepatitis B vaccine; Biological: 60μg Kangtai hepatitis B vaccine

• 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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2014-06-30
• Study Completion: 2015-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-24

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

Arm && Interventions

Group	Intervention	Description
20μg Engerix-B with 0-1-6 intervals	20μg Engerix-B hepatitis B vaccine	Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals
20μg CHO with 0-1-6 intervals	20μg CHO	Received three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals
20μg Kangtai with 0-1-6 intervals	20μg Kangtai hepatitis B vaccine	Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals
60μg Kangtai with 0-2 intervals	60μg Kangtai hepatitis B vaccine	Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals

Primary Outcome Measures

Name	Time	Method
Anti-HBs	at the second month after the final injection of each arm	Titers of hepatitis B virus surface antibody

Trial Locations

Locations (2)

Xuanhua District Center for Disease Control and Prevention; 🇨🇳 Xuanhua, Hebei, China

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