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. 2021 Sep 1;4(9):e2123622.
doi: 10.1001/jamanetworkopen.2021.23622.

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

Kevin Yau  1   2 , Kento T Abe  3   4 , David Naimark  1 , Matthew J Oliver  1 , Jeffrey Perl  2   5 , Jerome A Leis  1   6 , Shelly Bolotin  7   8   9 , Vanessa Tran  8   9 , Sarah I Mullin  1 , Ellen Shadowitz  1 , Anny Gonzalez  1 , Tatjana Sukovic  1 , Julie Garnham-Takaoka  5 , Keelia Quinn de Launay  4 , Alyson Takaoka  5 , Sharon E Straus  5 , Allison J McGeer  10 , Christopher T Chan  11 , Karen Colwill  4 , Anne-Claude Gingras  3   4 , Michelle A Hladunewich  1
Affiliations

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

Kevin Yau et al. JAMA Netw Open. .

Erratum in

  • Errors in Abstract and Figure 1.
    [No authors listed] [No authors listed] JAMA Netw Open. 2022 Feb 1;5(2):e221422. doi: 10.1001/jamanetworkopen.2022.1422. JAMA Netw Open. 2022. PMID: 35157065 Free PMC article. No abstract available.

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Oliver reported receiving fees from the Ontario Renal Network as a contracted regional medical lead outside the submitted work. Dr Perl reported receiving speaking honoraria and consultancy fees from Baxter Healthcare; grants from Agency for Healthcare Research and Quality grant support; speaking honoraria from Fresenius Medical Care, AstraZeneca, Davita Healthcare, and US Renal Care; and consultancy fees from LiberDi Dialysis outside the submitted work. Dr Tran reported that Public Health Ontario received funding from the Public Health Agency of Canada and test kits from the Canadian Immunity Task Force for COVID-19 serosurveillance studies. Public Health Ontario is also involved in a COVID-19 mix-and-match vaccine clinical trial examining safety and immunogenicity. Dr McGeer reported receiving an investigator-initiated grant from Pfizer; collaborative grant to the institution from Pfizer; investigator-initiated grant to the institution from Merck; and advisory board fees from Pfizer, Merck, Medicago Moderna, Janssen, GSK, and AstraZeneca outside the submitted work. Dr Colwill reported receiving funding from Medivolve Inc for initial development of an enzyme-linked immunosorbent assay at Sinai Health System outside the submitted work. Dr Gingras participates in the working party (testing) and working party (immunology) of the CITF, chairs the CIHR Institute of Genetics Advisory Board, and is a member of the SAB of the National Research Council of Canada Human Health Therapeutics Board. Dr Hladunewich reported receiving grants from Pfizer for a focal segmental glomerulosclerosis study, Ionis for a immunoglobulin A study, Chemocentryx for a focal segmental glomerulosclerosis study, Calliditas for an immunoglobulin A study, Roche for a preeclampsia study, and consultant fees from an Alynylam pregnancy study outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Immunoglobulin G (IgG) Response to Spike, Receptor Binding Domain (RBD), and Nucleocapsid Protein (NP) Antigens of SARS-CoV-2 Following 1 vs 2 Doses of BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis
HCW indicates health care worker; PCR, polymerase chain reaction.
Figure 2.
Figure 2.. Reactogenicity Rates Following BNT162b2 Vaccine by Symptom Severity
Localized and systemic symptoms that occurred after the first (A) and second (B) doses of the vaccine.
See this image and copyright information in PMC

References

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