Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

November 26, 2021 updated by: Suping Wang

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge.

This is a randomized, controlled trial. The study will evaluate the immunogenicity, immune persistence, and safety of 20 µg and 60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 4

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:

  • Having end-stage renal disease (ESRD) on maintenance hemodialysis
  • Aged between 18 and 70 years at enrollment
  • Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • Willing to adhere to the study protocol

Exclusion Criteria:

  • Being pregnant
  • Acute cytolysis in the last three months before enrollment
  • Any vaccination during the month preceding enrollment
  • Intolerance or allergy to any component of the vaccine
  • Ongoing opportunistic infection
  • Hepatitis C virus infection
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment
  • Immunosuppressive or immunomodulating treatment in the last six months
  • Renal transplantation or upcoming renal transplantation
  • Liver disease
  • Other immunocompromised condition not related to ESRD
  • An expected survival of < 6 months

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
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs Seroconversion Rate at Month 7
Time Frame: Month 7
Month 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HBs Seroconversion Rate at Month 42
Time Frame: Month 42
Month 42
Anti-HBs Seroconversion Rate at Month 36
Time Frame: Month 36
Month 36
Anti-HBs Seroconversion Rate at Month 30
Time Frame: Month 30
Month 30
Anti-HBs Seroconversion Rate at Month 24
Time Frame: Month 24
Month 24
Anti-HBs Concentration at Month 7
Time Frame: Month 7
Anti-HBs concentration at month 7 as measured by CMIA
Month 7
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 12
Time Frame: Month 12
Month 12
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
Occurrence of Adverse Events After Vaccination
Time Frame: Within 28 days after the vaccination
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine
Within 28 days after the vaccination
Anti-HBs Seroconversion Rate at Month 18
Time Frame: Month 18
Month 18

Other Outcome Measures

Outcome Measure
Time Frame
High-level Response Rate at Month 7
Time Frame: Month 7
Month 7
High-level Response Rate at Month 12
Time Frame: Month 12
Month 12
High-level Response Rate at Month 18
Time Frame: Month 18
Month 18
High-level Response Rate at Month 30
Time Frame: Month 30
Month 30
High-level Response Rate at Month 36
Time Frame: Month 36
Month 36
High-level Response Rate at Month 42
Time Frame: Month 42
Month 42
High-level Response Rate at Month 24
Time Frame: Month 24
Month 24

Collaborators and Investigators

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

Sponsor

Suping Wang

Collaborators

Centers for Disease Control and Prevention, China

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

December 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002001003004001

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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