Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
1 other identifier
interventional
300
1 country
2
Brief Summary
At present, chronic kidney disease population are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal. This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1, 2, and 6 in chronic kidney disease population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2019
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
May 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 24, 2019
May 1, 2019
8 months
May 23, 2019
May 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Month 7
Secondary Outcomes (10)
Anti-HBs concentration at month 7
Month 7
Occurrence of Adverse Events After Vaccination
Within 7 days after the vaccination
Anti-HBs Seroconversion Rate at Month 12
Month 12
Anti-HBs Concentration at Month 12
Month 12
Anti-HBs Seroconversion Rate at Month 18
Month 18
- +5 more secondary outcomes
Study Arms (3)
20 µg at months 0, 1, and 6
EXPERIMENTAL20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
20 µg at months 0, 1, 2,and 6
EXPERIMENTAL20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
60 µg at months 0, 1, 2,and 6
EXPERIMENTAL60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
Interventions
three-dose, 20 µg per dose
four-dose, 20 µg per dose
four-dose, 60 µg per dose
Eligibility Criteria
You may qualify if:
- Aged between 18 and 70 years at the enrolment
- Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
- Sign informed consent, willing to participate in this study
You may not qualify if:
- Being pregnant
- Intolerance or allergy to any component of the vaccine
- Any vaccination during the month preceding enrollment
- Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
- Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Central Hospital of Linfen
Linfen, China
The People's Hospital of Linfen
Linfen, China
Related Publications (3)
Yao T, Li Y, Zhang Y, Sun Y, Guo Y, Wang J, Song X, Zhang W, Wei B, Bai J, Wang H, Yu W, Wang H, Jiao L, Diao Y, Liu L, Shi S, Yang J, Ren X, Liu W, Fang J, Liang X, Wang S, Feng Y. Immunogenicity, Safety, and Persistence Induced by Triple- and Standard-Strength 4-Dose Hepatitis B Vaccination Regimens in Patients Receiving Hemodialysis. J Infect Dis. 2025 Apr 15;231(4):1049-1059. doi: 10.1093/infdis/jiae494.
PMID: 39378326DERIVEDHan Y, Cao N, Lu X, Yao T, Shi J, Wu Y, Dong S, Shao Z, Wang J, Liu H, Guo H, Chai G, Liu L, Wang F, Feng Y, Liang X, Wang S. Duration of immunogenicity of high-dose and prolonged-schedule hepatitis B vaccine among patients with chronic kidney disease: A one year follow-up study in China. Expert Rev Vaccines. 2022 Nov;21(11):1675-1682. doi: 10.1080/14760584.2022.2112951. Epub 2022 Aug 18.
PMID: 35968570DERIVEDFeng Y, Yao T, Han Y, Shi J, Dong S, Wu Y, Shao Z, Liu H, Guo H, Chai G, Liu L, Wang F, Wang J, Liang X, Wang S. Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2021 Jun;20(6):743-751. doi: 10.1080/14760584.2021.1915777. Epub 2021 May 31.
PMID: 34058948DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongliang Feng, PhD
Shanxi Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 24, 2019
Study Start
May 25, 2019
Primary Completion
February 1, 2020
Study Completion
December 1, 2023
Last Updated
May 24, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share