Immunogenicity of Hepatitis B Vaccination Among Drug Users

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial

Conditions
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Hepatitis B Vaccination

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 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

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

Sexes Eligible for Study
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Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 60 µg dose hepatitis B vaccine<br>Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine 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>Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6 | Biological: 20 µg dose hepatitis B vaccine<br>* three-dose, 20 µg per dose<br>|
| No Intervention: Control<br>Receive no vaccination during the study period | |

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 | 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 | Within 28 days after the vaccination, at Month 0, 1, and 6 | 
| Serious Adverse Events (SAE) Occurred During Month 12 |  | Month 0-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B vaccination, Immunogenicity, Randomized controlled trial, Drug abuse