Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 20 µg at months 0, 1, and 6 20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 |
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
three-dose, 20 µg per dose
|
Experimental: 20 µg at months 0, 1, 2,and 6 20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 20 µg per dose
|
Experimental: 60 µg at months 0, 1, 2,and 6 60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6 |
Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
four-dose, 60 µg per dose
|
Outcome Measures
Primary Outcome Measures
- Anti-HBs Seroconversion Rate at Month 7 [Month 7]
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Secondary Outcome Measures
- Anti-HBs concentration at month 7 [Month 7]
Anti-HBs concentration at month 7 as measured by CMIA
- Occurrence of Adverse Events After Vaccination [Within 7 days after the vaccination]
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
- Anti-HBs Seroconversion Rate at month 12 [Month 12]
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
- Anti-HBs concentration at month 12 [Month 12]
Anti-HBs concentration at month 12 as measured by CMIA
- Anti-HBs Seroconversion Rate at month 18 [Month 18]
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
- Anti-HBs concentration at month 18 [Month 18]
Anti-HBs concentration at month 18 as measured by CMIA
- Anti-HBs Seroconversion Rate at month 30 [Month 30]
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
- Anti-HBs concentration at month 30 [Month 30]
Anti-HBs concentration at month 30 as measured by CMIA
- Anti-HBs Seroconversion Rate at month 42 [Month 42]
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
- Anti-HBs concentration at month 42 [Month 42]
Anti-HBs concentration at month 42 as measured by CMIA
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Xinghualing Methadone Drug Point | Taiyuan | China |
Sponsors and Collaborators
- Shanxi Medical University
- Centers for Disease Control and Prevention, China
Investigators
- Principal Investigator: Suping Wang, PhD, Shanxi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018ZX10721202001002002