Study on New Strategies for Hepatitis B Virus Immunization
Comparative Immunogenicity of Hepatitis B Vaccine With Different Immunization Schedule in Primary Immune Adults Aged 25-55 in China
1 other identifier
interventional
1,169
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedJuly 24, 2024
July 1, 2024
1.5 years
July 17, 2024
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Anti-HBs
Titers of hepatitis B virus surface antibody
at the second month after the final injection of each arm
Study Arms (4)
20μg Engerix-B with 0-1-6 intervals
EXPERIMENTALReceived three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals
20μg Kangtai with 0-1-6 intervals
EXPERIMENTALReceived three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals
60μg Kangtai with 0-2 intervals
EXPERIMENTALReceived two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals
20μg CHO with 0-1-6 intervals
PLACEBO COMPARATORReceived three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals
Interventions
Eligibility Criteria
You may qualify if:
- aged 25-55 years
- negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wu Jianglead
Study Sites (2)
Huaibei District Center for Disease Control and Prevention
Huaibei, Anhui, 235000, China
Xuanhua District Center for Disease Control and Prevention
Xuanhua, Hebei, 075199, China
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Zhang
Beijing Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 23, 2024
Study Start
January 1, 2013
Primary Completion
June 30, 2014
Study Completion
December 31, 2015
Last Updated
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- the data will become available after publication permanent
- Access Criteria
- With consent of the principal investigator
The original primary outcome data will be shared