A Phase 4 interventional study of 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6 and 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6 in Hepatitis B Vaccine, sponsored by Shanxi Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Shanxi Medical University · Phase 4, Interventional, and Prevention
At present, Methadone Maintenance Treatment Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.
This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in Methadone Maintenance Treatment Patients
Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Shanxi Medical University is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 µg recombinant hepatitis B vaccine with three injections at months 0, 1, and 6
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6
Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6
three-dose, 20 µg per dose
four-dose, 20 µg per dose
four-dose, 60 µg per dose
Anti-HBs Seroconversion Rate at Month 7
Anti-HBs Seroconversion Rate at month 7 as measured by CMIA
Time frame: Month 7
Anti-HBs concentration at month 7
Anti-HBs concentration at month 7 as measured by CMIA
Time frame: Month 7
Occurrence of Adverse Events After Vaccination
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis
Time frame: Within 7 days after the vaccination
Anti-HBs Seroconversion Rate at month 12
Anti-HBs Seroconversion Rate at month 12 as measured by CMIA
Time frame: Month 12
Anti-HBs concentration at month 12
Anti-HBs concentration at month 12 as measured by CMIA
Time frame: Month 12
Anti-HBs Seroconversion Rate at month 18
Anti-HBs Seroconversion Rate at month 18 as measured by CMIA
Time frame: Month 18
Anti-HBs concentration at month 18
Anti-HBs concentration at month 18 as measured by CMIA
Time frame: Month 18
Anti-HBs Seroconversion Rate at month 30
Anti-HBs Seroconversion Rate at month 30 as measured by CMIA
Time frame: Month 30
Anti-HBs concentration at month 30
Anti-HBs concentration at month 30 as measured by CMIA
Time frame: Month 30
Anti-HBs Seroconversion Rate at month 42
Anti-HBs Seroconversion Rate at month 42 as measured by CMIA
Time frame: Month 42
Anti-HBs concentration at month 42
Anti-HBs concentration at month 42 as measured by CMIA
Time frame: Month 42
Plan to share: No
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Shanxi Medical University