Clinical trial NCT02991599: Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Official title: Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B, Vaccine
Immunogenicity
methadone maintenance treatment
Randomized Controlled Trial
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2016-12-13
Enrollment: 196
Sex: ALL
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: 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.

Detailed description: Comparison of 2 vaccination strategy against Hepatitis B in patients with Methadone Maintenance Treatment

Intervention:

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

Arm 2 : 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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: Anti-HBs Concentration at Month 18
timeFrame: Month 18
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
timeFrame: Month 18
measure: Anti-HBs Concentration at Month 30
timeFrame: Month 30
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
timeFrame: Month 30
measure: Anti-HBs Concentration at Month 42
timeFrame: Month 42
measure: Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
timeFrame: Month 42
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: Number and Rate of Participants With Anti-HBs High-level Response at Month 18
timeFrame: Month 18
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 30
timeFrame: Month 30
measure: Number and Rate of Participants With Anti-HBs High-level Response at Month 42
timeFrame: Month 42
Locations:
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.