NCT03962881

Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

At present, chronic kidney disease population 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 chronic kidney disease population.

Detailed description

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.

Conditions

• Hepatitis B Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	20 µg recombinant hepatitis B vaccine at months 0, 1, and 6	three-dose, 20 µg per dose
BIOLOGICAL	20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6	four-dose, 20 µg per dose
BIOLOGICAL	60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6	four-dose, 60 µg per dose

Timeline

• Start date: 2019-05-25
• Primary completion: 2020-02-01
• Completion: 2023-12-01
• First posted: 2019-05-24
• Last updated: 2019-05-24

Locations

2 sites across 1 country: China