NCT02959775

Brief Summary

Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection. This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users

Trial Health

100
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

November 7, 2016

Results QC Date

May 23, 2019

Last Update Submit

December 3, 2021

Conditions

Hepatitis B Vaccination

Keywords

Hepatitis B vaccinationImmunogenicityRandomized controlled trialDrug abuse

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 (6)

  • 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

  • +1 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

  • Anti-HBs Concentration at Month 6 Before the Third Injection

    Month 6 before the third injection

  • +2 more other outcomes

Study Arms (3)

60 µg dose hepatitis B vaccine

EXPERIMENTAL

Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6

Biological: 60 µg dose hepatitis B vaccine

20 µg dose hepatitis B vaccine

EXPERIMENTAL

Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6

Biological: 20 µg dose hepatitis B vaccine

Control

NO INTERVENTION

Receive no vaccination during the study period

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
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 70 years at the enrolment
  • current illicit drug users before drug rehabilitation
  • negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
  • having spent acute physiological detoxification phase

You may not qualify if:

  • any intolerance or allergy to any component of the vaccine
  • ongoing opportunistic infection
  • liver disease
  • hemopathy
  • cancer
  • unexplained fever in the last week before the recruiting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1283082. Epub 2017 Mar 16.

    PMID: 28301282RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

October 1, 2015

Last Updated

February 18, 2022

Results First Posted

February 18, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share