CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 480 enrolled
Drug / intervention
60 µg dose hepatitis B vaccine +1 morebiological
Likely dose
60 µg dose hepatitis B vaccinefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02959775
NCT02959775Phase 4Completed
CompareCT.gov

Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial

Shanxi Medical University·interventional·Posted Nov 9, 2016·Updated Feb 18, 2022

In Brief

A Phase 4 clinical trial evaluating 60 µg dose hepatitis B vaccine and 20 µg dose hepatitis B vaccine for Hepatitis B Vaccination. Completed, enrolled 480 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccination
Countries--
CollaboratorsCenters for Disease Control and Prevention, China

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 9, 2016
Enrollment StartAug 1, 2014
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.6 years ago

Interventions

60 µg dose hepatitis B vaccinebiological

three-dose, 60 µg per dose

20 µg dose hepatitis B vaccinebiological

three-dose, 20 µg per dose