NCT02991599

Brief Summary

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 methadone maintenance treatment patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 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

October 1, 2014

Completed
9 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

December 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 30, 2019

Completed
Last Updated

December 23, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

December 10, 2016

Results QC Date

May 23, 2019

Last Update Submit

November 26, 2021

Conditions

Hepatitis B Vaccine

Keywords

Hepatitis B, VaccineImmunogenicitymethadone maintenance treatmentRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Number and Rate of Participants With Anti-HBs Seroconversion at Month 7

    The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml.

    Month 7

Secondary Outcomes (11)

  • Anti-HBs Concentration at Month 7

    Month 7

  • Anti-HBs Concentration at Month 12

    Month 12

  • Number and Rate of Participants With Anti-HBs Seroconversion at Month 12

    Month 12

  • Occurrence of Adverse Events After Vaccination

    Within 7 days after the vaccination, at Month 0, 1, and 6

  • Occurrence of Adverse Events After Vaccination

    Within 28 days after the vaccination, at Month 0, 1, and 6

  • +6 more secondary outcomes

Other Outcomes (5)

  • Number and Rate of Participants With Anti-HBs High-level Response at Month 7

    Month 7

  • Number and Rate of Participants With Anti-HBs High-level Response at Month 12

    Month 12

  • Number and Rate of Participants With Anti-HBs High-level Response at Month 18

    Month 18

  • +2 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:

  • Aged between 18 and 70 years at the enrolment
  • 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
  • Intolerance or allergy to any component of the vaccine
  • Any vaccination during the month preceding enrollment
  • Ongoing opportunistic infection
  • Liver disease
  • Hematological disorder
  • Cancer
  • Unexplained fever the week before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. 2017 Apr 25;35(18):2443-2448. doi: 10.1016/j.vaccine.2017.03.034. Epub 2017 Mar 23.

    PMID: 28343774RESULT

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2016

First Posted

December 13, 2016

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

May 1, 2018

Last Updated

December 23, 2021

Results First Posted

July 30, 2019

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share