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

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

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.

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.

Inclusion Criteria:

• Aged between 18 and 70 years at the enrolment
• Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
• Sign informed consent, willing to participate in this study

Exclusion Criteria:

• Being pregnant
• Intolerance or allergy to any component of the vaccine
• Any vaccination during the month preceding enrollment
• Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
• Patients with Hepatitis B virus associated glomerulone nephritis or HBV DNA Positive