Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing
1 other identifier
observational
80
1 country
1
Brief Summary
Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to carry out a comprehensive study to evaluate the efficacy of hepatitis B vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in Chongqing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedStudy Start
First participant enrolled
July 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 10, 2022
March 1, 2022
2 months
March 5, 2019
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
HBsAb positive rate
The proportion of HBsAb in children with and without hepatitis B vaccine boosters
3-year
HBsAg-specific T cell response
The proportion of HBsAg-specific IFN-γ-producing T cells in children with and without hepatitis B vaccine boosters
3-year
HBsAb protective efficacy
Evaluate the changes in the protective efficacy of HBsAb after hepatitis B vaccine booster
3-year
Study Arms (2)
Hepatitis B vaccine booster
Children with anti-HBs at a level of\<10mIU/mL or \[10,100) mIU/mL before booster.
Observation
Children with anti-HBs at a level of \>100mIU/mL or \[10,100) mIU/mL before booster.
Interventions
Children with anti-HBs at a low level (\<10mIU/mL and \[10,100) mIU/mL) were received a dose of hepatitis B vaccine booster after informed consent.
Eligibility Criteria
1. History of allergy or adverse reaction of vaccine; 2. History of immunosuppressive treatment or immunodeficiency; 3. Any kind of vaccination in the past four weeks; 4. Any acute disease or anti-infective therapy in the past four weeks; 5. Fever history in the past one week (axillary temperature ≥ 38 ℃); 6. Blood transfusion history; 7. History of infectious diseases (hepatitis, AIDS, syphilis, gonorrhea, etc.); 8. The family history of HBV in three generations of lineal relatives; 9. Abnormal physical examination.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, China
Biospecimen
Separating serum, stored at -80 degrees Celsius
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yao Zhao, postdoctor
Chongqing Children's Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 8, 2019
Study Start
July 9, 2021
Primary Completion
September 9, 2021
Study Completion
December 31, 2025
Last Updated
March 10, 2022
Record last verified: 2022-03