Anti-Spike antibodies 3 months after SARS-CoV-2 mRNA vaccine booster dose in patients on hemodialysis: the prospective SENCOVAC study

Background Patients on hemodialysis are at high-risk for complications derived from coronavirus disease 2019 (COVID-19). The present analysis evaluated the impact of a booster vaccine dose and breakthrough severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections on humoral immunity 3 months after the booster dose. Methods This is a multicentric and prospective study assessing immunoglobulin G anti-Spike antibodies 6 and 9 months after initial SARS-CoV-2 vaccination in patients on hemodialysis that had also received a booster dose before the 6-month assessment (early booster) or between the 6- and 9-month assessments (late booster). The impact of breakthrough infections, type of vaccine, time from the booster and clinical variables were assessed. Results A total of 711 patients [67% male, median age (range) 67 (20-89) years] were included. Of these, 545 (77%) received an early booster and the rest a late booster. At 6 months, 64 (9%) patients had negative anti-Spike antibody titers (3% of early booster and 29% of late booster patients, P = .001). At 9 months, 91% of patients with 6-month negative response had seroconverted and there were no differences in residual prevalence of negative humoral response between early and late booster patients (0.9% vs 0.6%, P = .693). During follow-up, 35 patients (5%) developed breakthrough SARS-CoV-2 infection. Antibody titers at 9 months were independently associated with mRNA-1273 booster (P = .001), lower time from booster (P = .043) and past breakthrough SARS-CoV-2 infection (P < .001). Conclusions In hemodialysis patients, higher titers of anti-Spike antibodies at 9 months were associated with mRNA-1273 booster, lower time from booster and past breakthrough SARS-CoV-2 infection. Lay Summary Patients on hemodialysis present higher rates of complications derived from SARS-CoV-2 infections. Initial vaccination schedules have demonstrated suboptimal responses in those patients. The aim of the present study is to evaluate the time-course of the humoral response after a booster dose of SARS-CoV-2 RNA-based vaccines (BNT162b2 or mRNA-1273) in patients on hemodialysis. We included 711 patients that had received a booster dose: 545 (77%) 6 months before the initial vaccination and 166 (23%) between 6 and 9 months from the initial vaccination. After the booster, only 6 (<1%) patients presented persistent negative humoral response. During follow-up from Month 6 to Month 9, 35 patients (5%) developed a SARS-CoV-2 infection. Patients that received the booster later, breakthrough SARS-CoV-2 infection and mRNA-1273 booster were associated with higher anti-Spike titers.