key: cord-0890823-0wzwmyng
authors: Goupil, R.; Benlarbi, M.; Beaubien-Souligny, W.; Nadeau-Fredette, A.-C.; Debashree, C.; Goyette, G.; Lamarche, C.; Finzi, A.; Suri, R. S.
title: Short-term antibody response and tolerability of one dose of BNT162b2 vaccine in patients receiving hemodialysis
date: 2021-04-01
journal: nan
DOI: 10.1101/2021.03.30.21254652
sha: 56ea5b7871f3fc56f7ed6cbcc0824047b2e96db7
doc_id: 890823
cord_uid: 0wzwmyng

Background: Patients with end-stage kidney disease receiving in-center hemodialysis are at high risk of exposed to, and dying from, SARS-CoV-2. As impairments in both humoral and cellular immunity are common in this population, their response to vaccination against SARS-CoV-2 is uncertain. Methods: We have followed in-center hemodialysis patients in the Reseau Renal Quebecois since March 2020 with serial PCRs for COVID-19 and clinical outcomes. Plasma samples were taken from 58 patients from one center before, and 4 weeks after, vaccination with one dose of the BNT162b2 mRNA vaccine. Anti-RBD (region binding domain of the SARS-CoV-2 Spike protein) IgG levels were measured using ELISA and compared to levels in 32 health care worker (HCW) controls, as well as levels in convalescent plasma taken from 12 hemodialysis patients 4-12 weeks after COVID-19 infection. Patients were stratified based on evidence of previous infection with COVID-19 (positive PCR or antiRBD detectable at baseline). Results: Compared with health-care workers, hemodialysis patients without prior COVID-19 exhibited significantly lower anti-RBD IgG levels 4 weeks after vaccination (p=0.0007). Anti-RBD IgG was non-detectable in 1/16 (6%) of HCWs, and 25/46 (54%) of dialysis patients (p=0.0008). In dialysis patients previously infected with COVID-19, mean anti-RBD levels were significantly lower than their HCW controls (p=0.0031), but not signficantly different than those in convalescent plasma of recently infected dialysis patients (p=NS). No patients reported any symptoms 7 days after vaccination on a standardized questionnaire. Conclusion: The BNT162b2 vaccine was well-tolerated in hemodialysis patients, but failed to elicit a humoral immune response in >50% patients by 4 weeks. Whether these patients develop antibodies or T-cell responses after prolonged observation requires further study. Until then, we recommend that rigorous infection prevention and control measures in the dialysis unit and outside of it be continued to prevent SARS-CoV-2 infection in this susceptible population.

risk of exposed to, and dying from, SARS-CoV-2. As impairments in both humoral and cellular 48 immunity are common in this population, their response to vaccination against SARS-CoV-2 is 49 uncertain. IgG was non-detectable in 1/16 (6%) of HCWs, and 25/46 (54%) of dialysis patients (p=0.0008).

In dialysis patients previously infected with COVID-19, mean anti-RBD levels were significantly 64 lower than their HCW controls (p=0.0031), but not signficantly different than those in 65 convalescent plasma of recently infected dialysis patients (p=NS). No patients reported any 66 symptoms 7 days after vaccination on a standardized questionnaire. Patients with end-stage kidney disease receiving hemodialysis are uniquely vulnerable during 80 the COVID-19 pandemic. Self-isolation to avoid viral exposure is impossible, as most patients 81 must leave their homes 3 times weekly to receive their life-saving treatments, often in shared 82 spaces for prolonged periods. Once infected, risk of death is as high as 25% 1 . Some centers have 83 thus prioritized hemodialysis patients for vaccination.

To facilitate wider vaccine distribution during current shortages 2 , some jurisdictions including 86 Canada have opted to delay the recommended 3-week second dose of the BNT162b2 vaccine to 87 16 weeks 3 . Whether the reported clinical efficacy of >80% after a single dose 4 holds true for 88 dialysis patients is unknown, as they were not enrolled in this trial 4 , and many have impaired 89 humoral and cellular immune responses 5 .

We sought to determine if short-term antibody response is comparable between dialysis 92 patients and health-care workers (HCWs) vaccinated with a single dose of the BNT162b2 mRNA 93 vaccine, and how this compares to dialysis patients naturally infected with SARS-CoV-2.

We obtained plasma samples before, and 3-4 weeks after single dose vaccination with 98 BNT162b2, from 58 patients undergoing hemodialysis, and 32 HCWs, in Montreal, Canada. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 

Dialysis patients were considerably older than HCWs, with more comorbidities (Table 1) In a randomized trial, the BNT162b2 vaccine was clinically >80% effective after 3 weeks 4 . While 140 antibody levels that confer immunity are not known, our group has shown that all but one of (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 238 All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted April 1, 2021. 

COVID-19 Among US Dialysis Patients: Risk Factors 184 and Outcomes From a National Dialysis Provider

Delayed Second Dose versus Standard Regimen for

Covid-19 Vaccination

Safety and Efficacy of the BNT162b2 mRNA Covid-192

Chronic inflammation and hemodialysis reduce immune 194 competence of peripheral blood leukocytes in end-stage renal failure patients

Cross-Sectional Evaluation of Humoral 197 Responses against SARS-CoV-2 Spike

Decline of Humoral Responses 199 against SARS-CoV-2 Spike in Convalescent Individuals

A single BNT162b2 mRNA dose elicits antibodies 201 with Fc-mediated effector functions and boost pre-existing humoral and T cell 202 responses

Management of Outpatient Hemodialysis During 206 the COVID-19 Pandemic: Recommendations From the Canadian Society of Nephrology 207 COVID-19 Rapid Response Team

No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted