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

May 23, 2019 updated by: Suping Wang, Shanxi Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
Experimental: 20 µg at months 0, 1, 2,and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 20 µg per dose
Experimental: 60 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2,and 6
Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6
four-dose, 60 µg per dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HBs Seroconversion Rate at Month 7
Time Frame: Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Month 7

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Medical University

Collaborators

Centers for Disease Control and Prevention, China

Investigators

  • Principal Investigator: Yongliang Feng, PhD, Shanxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018ZX10721202001003001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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