NCT02963714

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Status
completed

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

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 8, 2016

Results QC Date

November 26, 2021

Last Update Submit

November 26, 2021

Conditions

Hepatitis B Vaccine

Keywords

Hepatitis B, VaccineRandomized Controlled TrialHemodialysisImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs Seroconversion Rate at Month 7

    Month 7

Secondary Outcomes (10)

  • Anti-HBs Seroconversion Rate at Month 42

    Month 42

  • Anti-HBs Seroconversion Rate at Month 36

    Month 36

  • Anti-HBs Seroconversion Rate at Month 30

    Month 30

  • Anti-HBs Seroconversion Rate at Month 24

    Month 24

  • Anti-HBs Concentration at Month 7

    Month 7

  • +5 more secondary outcomes

Other Outcomes (7)

  • High-level Response Rate at Month 7

    Month 7

  • High-level Response Rate at Month 12

    Month 12

  • High-level Response Rate at Month 18

    Month 18

  • +4 more other outcomes

Study Arms (2)

60 µg dose hepatitis B vaccine

EXPERIMENTAL

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

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

EXPERIMENTAL

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

Biological: 20 µg dose hepatitis B vaccine

Interventions

60 µg dose hepatitis B vaccineBIOLOGICAL

three-dose, 60 µg per dose

60 µg dose hepatitis B vaccine
20 µg dose hepatitis B vaccineBIOLOGICAL

three-dose, 20 µg per dose

20 µg dose hepatitis B vaccine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Feng Y, Shi X, Shi J, Gao L, Liu G, Cheng Y, Pan M, Li C, Wang J, Guo X, Zhang Y, Liang X, Wang S. Immunogenicity, antibody persistence, and safety of the 60 mug hepatitis B vaccine in hemodialysis patients: a multicenter, randomized, double-blind, parallel-controlled trial. Expert Rev Vaccines. 2017 Oct;16(10):1045-1052. doi: 10.1080/14760584.2017.1367667. Epub 2017 Aug 21.

    PMID: 28803502RESULT

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Suping Wang, PhD
Organization
Shanxi Medical University
spwang88@163.com
#86-351-4135103

Study Officials

  • Suping Wang

    Shanxi Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 15, 2016

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2018

Last Updated

February 14, 2022

Results First Posted

February 14, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share