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Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

Primary Purpose

Hepatitis B Vaccine

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
Sponsored by
Shanxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Vaccine focused on measuring Hepatitis B Vaccine, Randomized Controlled Trial, Chronic Kidney Disease Population, Immunogenicity, Long-term Immune Response

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Central Hospital of Linfen
  • The People's Hospital of Linfen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

20 µg at months 0, 1, and 6

20 µg at months 0, 1, 2,and 6

60 µg at months 0, 1, 2,and 6

Arm Description

20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6

20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6

60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6

Outcomes

Primary Outcome Measures

Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA

Secondary Outcome Measures

Anti-HBs concentration at month 7
Anti-HBs concentration at month 7 as measured by CMIA
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Anti-HBs Seroconversion Rate at Month 12
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Anti-HBs Concentration at Month 12
Anti-HBs Concentration at Month 12 as measured by CMIA
Anti-HBs Seroconversion Rate at Month 18
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Anti-HBs Concentration at Month 18
Anti-HBs Concentration at Month 18 as measured by CMIA
Anti-HBs Seroconversion Rate at Month 30
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Anti-HBs Concentration at Month 30
Anti-HBs Concentration at Month 30 as measured by CMIA
Anti-HBs Seroconversion Rate at Month 42
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Anti-HBs Concentration at Month 42
Anti-HBs Concentration at Month 42 as measured by CMIA

Full Information

First Posted
May 23, 2019
Last Updated
May 23, 2019
Sponsor
Shanxi Medical University
Collaborators
Centers for Disease Control and Prevention, China
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1. Study Identification

Unique Protocol Identification Number
NCT03962881
Brief Title
Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Official Title
Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 25, 2019 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanxi Medical University
Collaborators
Centers for Disease Control and Prevention, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Vaccine
Keywords
Hepatitis B Vaccine, Randomized Controlled Trial, Chronic Kidney Disease Population, Immunogenicity, Long-term Immune Response

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20 µg at months 0, 1, and 6
Arm Type
Experimental
Arm Description
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Arm Title
20 µg at months 0, 1, 2,and 6
Arm Type
Experimental
Arm Description
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
Arm Title
60 µg at months 0, 1, 2,and 6
Arm Type
Experimental
Arm Description
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
Intervention Type
Biological
Intervention Name(s)
20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
Intervention Description
three-dose, 20 µg per dose
Intervention Type
Biological
Intervention Name(s)
20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
Intervention Description
four-dose, 20 µg per dose
Intervention Type
Biological
Intervention Name(s)
60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
Intervention Description
four-dose, 60 µg per dose
Primary Outcome Measure Information:
Title
Anti-HBs Seroconversion Rate at Month 7
Description
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Time Frame
Month 7
Secondary Outcome Measure Information:
Title
Anti-HBs concentration at month 7
Description
Anti-HBs concentration at month 7 as measured by CMIA
Time Frame
Month 7
Title
Occurrence of Adverse Events After Vaccination
Description
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine
Time Frame
Within 7 days after the vaccination
Title
Anti-HBs Seroconversion Rate at Month 12
Description
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Time Frame
Month 12
Title
Anti-HBs Concentration at Month 12
Description
Anti-HBs Concentration at Month 12 as measured by CMIA
Time Frame
Month 12
Title
Anti-HBs Seroconversion Rate at Month 18
Description
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Time Frame
Month 18
Title
Anti-HBs Concentration at Month 18
Description
Anti-HBs Concentration at Month 18 as measured by CMIA
Time Frame
Month 18
Title
Anti-HBs Seroconversion Rate at Month 30
Description
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Time Frame
Month 30
Title
Anti-HBs Concentration at Month 30
Description
Anti-HBs Concentration at Month 30 as measured by CMIA
Time Frame
Month 30
Title
Anti-HBs Seroconversion Rate at Month 42
Description
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Time Frame
Month 42
Title
Anti-HBs Concentration at Month 42
Description
Anti-HBs Concentration at Month 42 as measured by CMIA
Time Frame
Month 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongliang Feng, PhD
Phone
#86-351-4135362
Email
fengyongliang048@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suping Wang, PhD
Phone
#86-351-4135103
Email
spwang88@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongliang Feng, PhD
Organizational Affiliation
Shanxi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Central Hospital of Linfen
City
Linfen
Country
China
Facility Name
The People's Hospital of Linfen
City
Linfen
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35968570
Citation
Han 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.
Results Reference
derived
PubMed Identifier
34058948
Citation
Feng 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.
Results Reference
derived

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Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

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