Dataset Information

Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis.

ABSTRACT:

Importance

Patients undergoing hemodialysis have a high mortality rate associated with COVID-19, and this patient population often has a poor response to vaccinations. Randomized clinical trials for COVID-19 vaccines included few patients with kidney disease; therefore, vaccine immunogenicity is uncertain in this population.

Objective

To evaluate the SARS-CoV-2 antibody response in patients undergoing chronic hemodialysis following 1 vs 2 doses of BNT162b2 COVID-19 vaccination compared with health care workers serving as controls and convalescent serum.

Design, setting, and participants

A prospective, single-center cohort study was conducted between February 2 and April 17, 2021, in Toronto, Ontario, Canada. Participants included 142 patients receiving in-center hemodialysis and 35 health care worker controls.

Exposures

BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine.

Main outcomes and measures

SARS-CoV-2 IgG antibodies to the spike protein (anti-spike), receptor binding domain (anti-RBD), and nucleocapsid protein (anti-NP).

Results

Among the 142 participants undergoing maintenance hemodialysis, 94 (66%) were men; median age was 72 (interquartile range, 62-79) years. SARS-CoV-2 IgG antibodies were measured in 66 patients receiving 1 vaccine dose following a public health policy change, 76 patients receiving 2 vaccine doses, and 35 health care workers receiving 2 vaccine doses. Detectable anti-NP suggestive of natural SARS-CoV-2 infection was detected in 15 of 142 (11%) patients at baseline, and only 3 patients had prior COVID-19 confirmed by reverse transcriptase polymerase chain reaction testing. Two additional patients contracted COVID-19 after receiving 2 doses of vaccine. In 66 patients receiving a single BNT162b2 dose, seroconversion occurred in 53 (80%) for anti-spike and 36 (55%) for anti-RBD by 28 days postdose, but a robust response, defined by reaching the median levels of antibodies in convalescent serum from COVID-19 survivors, was noted in only 15 patients (23%) for anti-spike and 4 (6%) for anti-RBD in convalescent serum from COVID-19 survivors. In patients receiving 2 doses of BNT162b2 vaccine, seroconversion occurred in 69 of 72 (96%) for anti-spike and 63 of 72 (88%) for anti-RBD by 2 weeks following the second dose and median convalescent serum levels were reached in 52 of 72 patients (72%) for anti-spike and 43 of 72 (60%) for anti-RBD. In contrast, all 35 health care workers exceeded the median level of anti-spike and anti-RBD found in convalescent serum 2 to 4 weeks after the second dose.

Conclusions and relevance

This study suggests poor immunogenicity 28 days following a single dose of BNT162b2 vaccine in the hemodialysis population, supporting adherence to recommended vaccination schedules and avoiding delay of the second dose in these at-risk individuals.

SUBMITTER: Yau K

PROVIDER: S-EPMC8414193 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background & aimsPatients undergoing dialysis are less likely to develop immune responses to SARS-CoV-2 vaccine. Malnutrition is common in the dialysis population. However, whether malnutrition contributes to the impaired immunogenicity remains unknown. The aim of this study was to assess the association between nutritional status and SARS-CoV-2 vaccine response in patients receiving maintenance hemodialysis.MethodsA total of 206 hemodialysis patients (mean age, 67 ± 13 years) without prior SARS-CoV-2 infection were examined for the primary outcome of seroconversion, defined as the detection of IgG antibodies (≥50 AU/mL) to the receptor-binding domain of the S1 spike protein of SARS-CoV-2 one month after a priming dose of ChAdOx1 nCoV-19, an adenovirus-vectored vaccine. Nutritional status was assessed by using the Controlling Nutritional Status (CONUT) score, an objective indicator of nutrition incorporating serum albumin, total cholesterol, and total lymphocyte count, as well as the subjective global assessment (SGA).ResultsOverall, 16.5% of patients were classified as malnourished, and 64.1% of patients were at risk for malnutrition based on the CONUT score. Anti-SARS-CoV-2 IgG were the highest in patients with normal nutrition. In multivariate logistic regression analyses adjusted for age, sex, comorbidities, and use of immunosuppressants, patients with malnutrition remained less likely to develop an antibody response than those with normal nutrition (odds ratio 0.23, 95% CI, 0.07-0.76). SGA was a significant predictor of anti-SARS-CoV-2 IgG seroconversion in univariate but not multivariate analyses.ConclusionsMalnutrition according to CONUT score is associated with impaired humoral responses to SARS-CoV-2 vaccination in patients undergoing hemodialysis. Our results highlight the importance of incorporating nutritional assessment into routine dialysis care to identify patients at risk for suboptimal immune responses after SARS-CoV-2 vaccination. Further research is needed to determine whether nutritional intervention can improve immune responses in these vulnerable patients.