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

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.

Timeline

Start

2019-05-25

Primary completion

2020-02

Completion

2023-12

Publications

• Yao T, Li Y, Zhang Y, Sun Y, Guo Y, Wang J, Song X, Zhang W, Wei B, Bai J, Wang H, Yu W, Wang H, Jiao L, Diao Y, Liu L, Shi S, Yang J, Ren X, Liu W, Fang J, Liang X, Wang S, Feng Y. Immunogenicity, Safety, and Persistence Induced by Triple- and Standard-Strength 4-Dose Hepatitis B Vaccination Regimens in Patients Receiving Hemodialysis. J Infect Dis. 2025 Apr 15;231(4):1049-1059. doi: 10.1093/infdis/jiae494.
• Han Y, Cao N, Lu X, Yao T, Shi J, Wu Y, Dong S, Shao Z, Wang J, Liu H, Guo H, Chai G, Liu L, Wang F, Feng Y, Liang X, Wang S. Duration of immunogenicity of high-dose and prolonged-schedule hepatitis B vaccine among patients with chronic kidney disease: A one year follow-up study in China. Expert Rev Vaccines. 2022 Nov;21(11):1675-1682. doi: 10.1080/14760584.2022.2112951. Epub 2022 Aug 18.
• Feng Y, Yao T, Han Y, Shi J, Dong S, Wu Y, Shao Z, Liu H, Guo H, Chai G, Liu L, Wang F, Wang J, Liang X, Wang S. Immunogenicity and safety of a high-dose and prolonged-schedule hepatitis B vaccine among chronic kidney disease patients: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2021 Jun;20(6):743-751. doi: 10.1080/14760584.2021.1915777. Epub 2021 May 31.

Drugs

Indications