NCT02963714

Immunogenicity of Hepatitis B Vaccination in Hemodialysis Patients

Immunogenicity and Persistence of Intramuscular High Dose Recombinant Hepatitis B Vaccine in Hemodialysis Patients in China: a Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Suping Wang · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatitis B Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	60 µg dose hepatitis B vaccine	three-dose, 60 µg per dose
BIOLOGICAL	20 µg dose hepatitis B vaccine	three-dose, 20 µg per dose

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-07-01
• Completion: 2018-07-01
• First posted: 2016-11-15
• Last updated: 2022-02-14
• Results posted: 2022-02-14