Clinical trial NCT02959775: Immunogenicity of Hepatitis B Vaccination Among Drug Users
Official title: Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Vaccination
Keywords: Hepatitis B vaccination
Immunogenicity
Randomized controlled trial
Drug abuse
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2016-11-09
Enrollment: 480
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Comparison of 2 vaccination strategy against Hepatitis B in Drug Users

Intervention:

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

Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 3 : Receive no vaccination during the study period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs Concentration at Month 7
timeFrame: Month 7
measure: Anti-HBs Concentration at Month 12
timeFrame: Month 12
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
timeFrame: Month 12
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination, at Month 0, 1, and 6
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 28 days after the vaccination, at Month 0, 1, and 6
measure: Serious Adverse Events (SAE) Occurred During Month 12
timeFrame: Month 0-12
Other outcomes:
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 7
timeFrame: Month 7
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 12
timeFrame: Month 12
measure: Anti-HBs Concentration at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
timeFrame: Month 6 before the third injection
Locations:
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.