Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: 60 µg dose hepatitis B vaccine
* Biological: 20 µg dose hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 µg dose hepatitis B vaccine<br>60 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 60 µg dose hepatitis B vaccine<br>* three-dose, 60 µg per dose<br>|
| Experimental: 20 µg dose hepatitis B vaccine<br>20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6 | Biological: 20 µg dose hepatitis B vaccine<br>* three-dose, 20 µg per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml. | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Concentration at Month 7 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 7 | 
| Anti-HBs Concentration at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 12 | 
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 12 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 12 | 
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine | Within 7 days after the vaccination, at Month 0, 1, and 6 | 
| Occurrence of Adverse Events After Vaccination | Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine | Within 28 days after the vaccination, at Month 0, 1, and 6 | 
| Anti-HBs Concentration at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 18 | 
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 18 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 18 | 
| Anti-HBs Concentration at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 30 | 
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 30 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 30 | 
| Anti-HBs Concentration at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） | Month 42 | 
| Number and Rate of Participants With Anti-HBs Seroconversion at Month 42 | The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ） . The accepted protective serum anti-HBs level was ≥10 mIU/ml | Month 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Vaccine, Immunogenicity, methadone maintenance treatment, Randomized Controlled Trial