Clinical trial NCT03962816: Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Official title: A Prospective Study on the Immunogenicity and Persistence of Hepatitis B Vaccine in Methadone Maintenance Treatment Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B Vaccine
Randomized Controlled Trial
Methadone Maintenance Treatment Patients
Immunogenicity
Long-term Immune Response
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2019-05-24
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients

Detailed description: Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility criteria: Inclusion Criteria:

* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* Patient with HIV Infection
* The use of immunosuppressive agents in patients with nearly three months

Primary outcomes:
measure: Anti-HBs Seroconversion Rate at Month 7
timeFrame: Month 7
Secondary outcomes:
measure: Anti-HBs concentration at month 7
timeFrame: Month 7
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination
measure: Anti-HBs Seroconversion Rate at month 12
timeFrame: Month 12
measure: Anti-HBs concentration at month 12
timeFrame: Month 12
measure: Anti-HBs Seroconversion Rate at month 18
timeFrame: Month 18
measure: Anti-HBs concentration at month 18
timeFrame: Month 18
measure: Anti-HBs Seroconversion Rate at month 30
timeFrame: Month 30
measure: Anti-HBs concentration at month 30
timeFrame: Month 30
measure: Anti-HBs Seroconversion Rate at month 42
timeFrame: Month 42
measure: Anti-HBs concentration at month 42
timeFrame: Month 42
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Xinghualing Methadone Drug Point
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng Y, Yao T, Gao Y, Li H, Dong S, Wu Y, Liu Y, Li J, Liu C, Liu J, Xue T, Yuan Y, Wu J, Wang F, Liang X, Wang S. Immunogenicity, safety, and compliance of high- and standard-strength four-dose hepatitis B vaccination regimens in patients receiving methadone maintenance therapy in China: a randomized, parallel-arm controlled trial. Expert Rev Vaccines. 2021 Dec;20(12):1629-1635. doi: 10.1080/14760584.2021.1977629. Epub 2021 Sep 16.