- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959775
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 60 µg dose hepatitis B vaccine
Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6
|
three-dose, 60 µg per dose
|
Experimental: 20 µg dose hepatitis B vaccine
Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6
|
three-dose, 20 µg per dose
|
No Intervention: Control
Receive no vaccination during the study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
Time Frame: 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 12
Time Frame: Month 12
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).
|
Month 12
|
Anti-HBs Concentration at Month 7
Time Frame: Month 7
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).
|
Month 7
|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
Time Frame: 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
Time Frame: Within 7 days after the vaccination, at Month 0, 1, and 6
|
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
Time Frame: Within 28 days after the vaccination, at Month 0, 1, and 6
|
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
Time Frame: Month 0-12
|
Month 0-12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and Rate of Participants With Anti-HBs High-level Response at Month 7
Time Frame: Month 7
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA.
and anti-HBs concentrations ≥100 mIU/ml were high-level response.
|
Month 7
|
Number and Rate of Participants With Anti-HBs High-level Response at Month 12
Time Frame: Month 12
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA.
and anti-HBs concentrations ≥100 mIU/ml were high-level response.
|
Month 12
|
Anti-HBs Concentration at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
|
Anti-HBs concentration at month 6 before the third injection by CMIA
|
Month 6 before the third injection
|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA.
The accepted protective serum anti-HBs level was ≥10 mIU/ml.
|
Month 6 before the third injection
|
Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
Time Frame: Month 6 before the third injection
|
The measurements of anti-HBs antibodies were determined quantitatively by CMIA.
and anti-HBs concentrations ≥100 mIU/ml were high-level response.
|
Month 6 before the third injection
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 2012ZX10002001003004002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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