Long‐term humoral immunity decline in hemodialysis patients following severe acute respiratory syndrome coronavirus 2 vaccination: A cohort study

Abstract

Background and Aims Dialysis patients are extremely vulnerable to severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection with high rates of hospitalization and mortality rates. In January 2021, the University of Virginia Dialysis Program initiated a program‐wide vaccination campaign to administer the Pfizer BioNTech messenger RNA SARS‐CoV‐2 (BNT162b2) vaccine. The aim of this study was to characterize the long‐term time‐dependent decline in humoral immunity in hemodialysis patients. Methods A prospective cohort study measuring serial monthly semiquantitative IgG antibody levels to the SARS‐CoV‐2 spike protein receptor binding domain in fully vaccinated in‐center hemodialysis patients. Samples were collected monthly and tested for anti‐SARS‐CoV‐2 antibodies against the anti‐spike S1 domain for 2–6 months post full vaccination. Results were presented as internationally harmonized binding antibody units (BAU/ml). To analyze the change in antibody levels over time, a linear mixed model with random intercept and random slope was used for longitudinal antibody levels. A multivariable model was used to estimate the slope of antibody levels by adjusting for selected patient characteristics. Based on the estimated intercepts and slopes for each subject from the unadjusted model, 10‐month antibody levels were projected. Results The mean baseline antibody level was 647.59 BAU/ml and 87.88% (29/33) of patients were considered qualitatively positive. Two patients were negative at baseline and an additional two had borderline results. Patient antibody levels declined at an adjusted average rate of 31% per month. At 6 months postvaccination, 40% of patients remaining in the cohort possessed either negative or borderline IgG antibody levels. Projecting future antibody levels suggests that 65% of the cohort will progress to borderline or negative antibody levels at 10 months post full vaccination. Conclusion The long‐term vaccine response following vaccination with the BNT162b2 in hemodialysis patients was characterized. Our data add to the limited pool of data in this patient population and emphasize the critical need for vaccine boosters.

SARS‐CoV‐2 booster effect and waning immunity in hemodialysis patients: A cohort study

“…In earlier results, 40% of the cohort transitioned from positive to negative antibody status at 6 months post‐two‐dose vaccination 5 . Encouragingly, a third dose appears to restore antibodies to high levels, though these waned quickly in the ensuing weeks.…”

“…In earlier results, 40% of the cohort transitioned from positive to negative antibody status at 6 months post‐two‐dose vaccination. 5 Encouragingly, a third dose appears to restore antibodies to high levels, though these waned quickly in the ensuing weeks. Similar trends of antibody decline are seen in healthy individuals, although dialysis patients may differ from the general population with reduced peak levels and lower seroconversion rates.…”

“…Clinical data were obtained as previously described. 5 Of 35 hemodialysis patients in the original cohort, 27 (77.1%) received a third dose of BNT162b2, and 20/27 (74%) had complete data (4-time point measurements): pre-booster (mean of 6 weeks pre-booster) and 2, 6, and 11 weeks post-booster. Two weeks was used to attain peak/initial antibody levels.…”

“… 4 We previously reported long‐term humoral responses to two doses of BNT162b2 in a cohort of hemodialysis patients. 5 Six months after full vaccination, 40% of patients' anti‐spike protein IgG levels were either undetectable or borderline. Here, we report responses to the first booster of the BNT162b2 vaccine in these patients.…”

“…However, antibody response and booster effectiveness are diminished in dialysis patients compared with the general healthy population 4 . We previously reported long‐term humoral responses to two doses of BNT162b2 in a cohort of hemodialysis patients 5 . Six months after full vaccination, 40% of patients' anti‐spike protein IgG levels were either undetectable or borderline.…”