Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Status Completed

Clinical Trial Summary

Intramuscular injection of 40 μg hepatitis B vaccine in a standard three-dose schedule or a four-dose schedule is recommended for hemodialysis patients. However, seroconversion rates are inadequate and persistence of immunity remains a challenge. 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 hemodialysis patients.

Clinical Trial Description

Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group.The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02963714
Study type	Interventional
Source	Shanxi Medical University
Contact
Status	Completed
Phase	Phase 4
Start date	December 2014
Completion date	July 2018

View Details

See also
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