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Observational Study
. 2021 Oct;78(4):571-581.
doi: 10.1053/j.ajkd.2021.06.002. Epub 2021 Jun 24.

Humoral and Cellular Responses to mRNA-1273 and BNT162b2 SARS-CoV-2 Vaccines Administered to Hemodialysis Patients

Affiliations
Observational Study

Humoral and Cellular Responses to mRNA-1273 and BNT162b2 SARS-CoV-2 Vaccines Administered to Hemodialysis Patients

José Jesús Broseta et al. Am J Kidney Dis. 2021 Oct.

Abstract

Rationale & objective: Patients with kidney failure who are receiving maintenance dialysis have a higher risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and worse clinical outcomes after coronavirus disease 2019 (COVID-19) than the general population. Therefore, immunization against SARS-CoV-2 with effective vaccines is an important component of health-maintenance strategies for these patients. This study evaluated the humoral and cellular responses to messenger RNA (mRNA) SARS-CoV-2 vaccines in this population.

Study design: Observational prospective multicenter cohort study.

Setting & participants: 205 patients treated at 3 dialysis units at the Hospital Clínic of Barcelona (Spain) were vaccinated from February 3 to April 4, 2021, and followed until April 23, 2021.

Exposure: Immunization with either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 mRNA vaccine.

Outcome: Seroconversion, defined as the detection of IgG antibodies to the receptor-binding domain of the S1 spike antigen of SARS-CoV-2 (anti-S1-RBD IgG), and the identification of activated CD4+T cells 3 weeks after completing vaccination. Anti-S1-RBD IgG levels were also analyzed as a secondary outcome.

Analytical approach: Univariate and multivariable logistic and multiple linear regression models were used to evaluate the associations between vaccination and study outcomes.

Results: We found that 97.7% of 175 vaccinated patients who were seronegative at baseline developed a response (humoral, cellular, or both); 95.4% of these patients seroconverted, while 62% of those tested for cellular immunity had a positive response. Greater age and immunosuppressive treatment were associated with lower antibody levels.

Limitations: Mandatory vaccine administration by health authorities. Anti-S1-RBD IgG levels were reported up to 150U/mL and cellular immune responses were characterized qualitatively. Antibody assay and cellular response assessment may not be comparable with previously published laboratory approaches.

Conclusions: Immunization with mRNA vaccines generated a humoral and cellular immune response in a high proportion of patients with kidney failure receiving maintenance dialysis. These findings as well as the high risk of infection and poor clinical outcomes among these patients make their vaccination a health priority.

Keywords: Antibody response; COVID-19; COVID-19 vaccines; SARS-CoV-2; cellular response; end-stage renal disease (ESRD); hemodialysis; humoral response; immunogenicity; immunosuppression; mRNA vaccines; seroconversion.

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Figures

Figure 1
Figure 1
Flow diagram with the number of individuals, eligibility, reasons for nonparticipation or loss to follow-up, and vaccine received, at each stage of the study.
Figure 2
Figure 2
Cellular, humoral and overall responses after completing vaccination.
Figure 3
Figure 3
Anti–S1-RBD IgG (A) with each vaccine type after the first and second doses, (B) by age groups after the first and second dose of both mRNA vaccines, and (C) comparing those seronegative and seropositive at baseline (BL). Data represented as median and interquartile range.

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