60 µg dose hepatitis B vaccine
Biologicalthree-dose, 60 µg per dose
Completed
NCT Number: NCT02991599
Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients
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.
Completed
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
20 µg dose hepatitis B vaccine
Biologicalthree-dose, 20 µg per dose
Primary outcomes
-
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.
Secondary outcomes
-
Anti-HBs Concentration at Month 7
Time frame: Month 7
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
-
Anti-HBs Concentration at Month 12
Time frame: Month 12
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
-
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
-
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 vaccine
-
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 vaccine
-
Anti-HBs Concentration at Month 18
Time frame: Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
-
Number and Rate of Participants With Anti-HBs Seroconversion at Month 18
Time frame: 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
-
Anti-HBs Concentration at Month 30
Time frame: Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
-
Number and Rate of Participants With Anti-HBs Seroconversion at Month 30
Time frame: 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
-
Anti-HBs Concentration at Month 42
Time frame: Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）
-
Number and Rate of Participants With Anti-HBs Seroconversion at Month 42
Time frame: 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
Other outcomes
-
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.
-
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.
-
Number and Rate of Participants With Anti-HBs High-level Response at Month 18
Time frame: Month 18
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
-
Number and Rate of Participants With Anti-HBs High-level Response at Month 30
Time frame: Month 30
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
-
Number and Rate of Participants With Anti-HBs High-level Response at Month 42
Time frame: Month 42
The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.
Sponsors and collaborators
Lead sponsor
Shanxi Medical University
Other
Collaborators
- Centers for Disease Control and Prevention, China
Registry information
Official study title
Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Methadone Maintenance Treatment Patients in China: a Randomized Controlled Trial
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2018
- First posted
- Dec 13, 2016
- Registry last updated
- Dec 23, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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