Risk Factors for Low Humoral Response to BNT-162b2 In Hemodialysis Patients

Abstract

Introduction Maintenance Hemodialysis (HD) patients are at higher risk of both infection and mortality associated with the new coronavirus 2. Immunization through large-scale vaccination is the cornerstone of infection prevention in this population. This study aims to identify risk factors for low response to the BNT-162b2 (Pfizer BioNTech) vaccine in a HD cohort. Materials and Methods Observational prospective study of a HD group followed in a Portuguese Public Founded Hemodialysis Center who received BNT-162b2 vaccination. Specific anti-Spike IgG was evaluated as arbitrary units per milliliter (AU/mL) on two separate occasions: 3 weeks after the first dose and 3 weeks after the second. IgG titers, Non-Responders (NR), and Weak-Responders (WR) after each dose were evaluated against risk factors that included demographic, clinical and analytical variables. Results Humoral response evaluated by IgG anti-Spike levels showed a strong correlation with Charlson comorbidity index (CCI) and intact parathormone (iPTH) after each inoculation (1st dose: ρ=−0.64/0.54; 2nd dose: ρ=−0.66/0.63, respectively; p<0.01 throughout). After completing both doses: 1) NR were associated with female sex (p<0.01), lower albumin and iPTH (p=0.01); 2) WR showed higher CCI, older age, lower iPTH and lower albumin (p=<0.01, p=0.03, p<0.01, p=0.05, respectively) and, consistently, associated with CCI over 8, age over 75, iPTH under 150 ng/L, female sex, dialysis vintage under 24 months and central venous catheter (CVC) over arteriovenous fistula (p=0.01, p=0.03, p<0.01, p=0.01, p=0.01, p<0.01, respectively). A binary regression model using CCI, sex (male) and CVC was statistically significant in prediction of WR after the 2nd dose with OR (95% CI): 1.81 (1.06-3.08); 0.05 (0.01-0.65); 13.55 (1.06-174.18), respectively (p=0.01). Conclusion Older age, higher CCI, lower iPTH and albumin, CVC as vascular access and recent hemodialysis initiation (less than 2 years) associate with lower response to vaccination in our study. A higher comorbidity burden is suggested as a more significant surrogate marker for low immunogenicity rather than age alone. Identifying HD patients as a population at high-risk for low response to vaccination is essential for proper policy-making, facilitating the implementation of adequate and individualized contingency protocols.