MedTrace Logo

Immunogenicity of Hepatitis B Vaccination Among Drug Users

NCT02959775 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-02-18

Study results available
· View outcomes & findings →

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

Conditions

  • Hepatitis B Vaccination

Interventions

BIOLOGICAL

60 µg dose hepatitis B vaccine

three-dose, 60 µg per dose

BIOLOGICAL

20 µg dose hepatitis B vaccine

three-dose, 20 µg per dose

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    collaborator OTHER_GOV

  • Shanxi Medical University

    lead OTHER

Principal Investigators

  • Suping Wang · Shanxi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-05-31
Completion
2015-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02959775 on ClinicalTrials.gov