Immunogenicity of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients

Hepatitis B Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991599
• Other study ID #: 2012ZX10002001003004003
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: May 2018

Study information

• Verified date: November 2021
• Source: Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: May 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine

Intervention

Biological:
• 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
• 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Medical University	Centers for Disease Control and Prevention, China

References & Publications (1)

Shi J, Feng Y, Gao L, Feng D, Yao T, Shi S, Zhang Y, Liang X, Wang S. Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized, double-blinded, parallel-controlled trial. Vaccine. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and Rate of Participants With Anti-HBs High-level Response at 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
Other	Number and Rate of Participants With Anti-HBs High-level Response at 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
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 18	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/mL were high-level response.	Month 18
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 30	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/mL were high-level response.	Month 30
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 42	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/mL were high-level response.	Month 42
Primary	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	Anti-HBs Concentration at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )	Month 7
Secondary	Anti-HBs Concentration at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Anti-HBs Concentration at Month 18	The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )	Month 18
Secondary	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
Secondary	Anti-HBs Concentration at Month 30	The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )	Month 30
Secondary	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
Secondary	Anti-HBs Concentration at Month 42	The measurements of anti-HBs antibodies were determined quantitatively by CMIA( Chemiluminescent Microparticle Immunoassay )	Month 42
Secondary	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