Factors Affecting Seroconversion Rate Following Hepatitis B Vaccination in Patients with Stage 4 Chronic Kidney Disease

Abstract

Aim: To assess the seroconversion rate following hepatitis B vaccination in patients with stage 4 chronic kidney disease (CKD) and to determine the factors associated with non-response to vaccination. Study Design: A prospective quantitative cohort study. Setting and Duration of Study: Armadale Renal Service, Armadale Hospital, Western Australia, July 2022 to January 2025. Background: Preventing the blood borne hepatitis B virus through vaccination is crucial for the high-risk haemodialysis patients. However, these individuals often exhibit low vaccine response rates due to declining immunity as kidney function deteriorates. While early vaccination before dialysis is suggested, a global consensus on the most effective CKD stage for initiation remains elusive. Method: Patients with stage 4 CKD (eGFR 15-29 ml/min/1.73m21.73M2) were enrolled in the study. Eligible patients with Hepatitis B surface Antibodies (HBsAb) <10 mIU/mL were recruited with informed consent. They received 40mcg of H_B_VAX II® intramuscularly in the deltoid muscle at 0 -1- 6 - month interval. Vaccine response, defined as HBsAb >10 mIU/mL, was measured six-eight weeks post vaccination. Response rate, patient and clinical factors were entered into the Statistical Package for Social Sciences version 29.0 for Windows for data analysis. Data were expressed as mean ± Standard Deviation, results analysed using t-tests and chi-square χ2 tests.  P value <0.05 as statistically significant. Results: Of the 106 enrolled patients (Males-71, Females-35), 99 (Males-67, Females-32) completed the course; seven deceased patients with incomplete vaccination were excluded for data analysis. Vaccination response rate was 47.47% (n= 47) while 52.52% (n=52) were non-responders (P=0.001). Factors negatively associated with vaccine response included older age group (P=0.001), presence of cardiovascular disease (P=0.011), Vitamin D3 deficiency (P=0.028), lower transferrin saturation (P =0.045), and presence of multiple comorbidities (P=0.017). Conclusion: This study showed a low hepatitis B vaccine response rate even in stage 4 CKD, underscoring the importance of early vaccination before progression to dialysis requirement. Identifying the factors that influence the response rate can aid in individualizing vaccination management strategy.