Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease

BackgroundChronic kidney disease (CKD) contributes to global mortality and morbidity, also due to infectious complications resulting from immune system dysregulation. Recently, respiratory syncytial virus (RSV) vaccines based on the prefusion F (preF) glycoprotein have been licensed for prevention of severe disease in elderly and in patients with comorbidities, but data on immunogenicity in patients with CKD is scarce. MethodsWe characterized humoral and cellular immunogenicity of 75 patients with CKD stages G3a to G5d both before and 14 (IQR 2) days after vaccination with an adjuvanted protein-based RSVpreF3-vaccine using ELISA and flow cytometry. Data on adverse events were collected through a self-reported questionnaire. ResultsVaccination led to a significant induction of RSV-specific CD4 T-cells (p<0.0001) and the increase did not differ between the CKD-stages. CD8 T-cells were not specifically induced. Despite high seroprevalence prior to vaccination, quantitative levels of RSV-specific immunoglobulins IgG and F protein-specific IgG were significantly induced upon vaccination (both p<0.0001), with a less pronounced increase in patients with advanced CKD. Urinary albumin-creatinine-ratio (UACR) was shown to be predictive of vaccine response in a multivariate regression model using age, serum creatinine and urea as covariates (p=0.035) The vaccine was well tolerated with mostly transient adverse events at the injection site. ConclusionsRSV-vaccination led to a robust CD4 T-cell and humoral response in patients with CKD with less pronounced effects in those with high-grade proteinuria. Long-term data on immunogenicity and correlation with clinical outcomes are warranted to define optimal vaccination strategies. Key learning points- What was known: There is limited data on RSV-vaccine immunogenicity in patients with CKD despite them being a high-risk group for developing severe RSV-associated lower respiratory tract infection - This study adds: Administration of the AS01E-adjuvanted RSVpreF3-vaccine significantly induces RSV-specific IgG and CD 4 T-cells in patients with CKD, including those on hemodialysis and under medical immunosuppression. Humoral vaccine response is reduced in advanced CKD and inversely correlates with UACR - Potential impact: RSV-vaccination is safe and immunogenic in patients with CKD, supporting the integration of RSV-vaccination into routine preventive care for the CKD-population