Antibody Status, Disease History, and Incidence of SARS-CoV-2 Infection Among Patients on Chronic Dialysis

Cohen, David S.; Sibbel, Scott; Marlowe, Gilbert; Bludorn, Kelsey; Miller, Dawn M.; Kelley, Tara; Connaire, Jeffrey; Young, Amy; Tentori, Francesca; Brunelli, Steven M.

doi:10.1681/asn.2021030387

Cited by 24 publications

(31 citation statements)

References 10 publications

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“…To attain the goal of reducing COVID-19 related mortality, current policies prioritized vaccination of frail populations including patients on maintenance hemodialysis 3 . This group of patients is particularly at risk of COVID-19 because includes subjects with advanced age and compromised immunity 4 , moreover, the thrice-a-week in-center haemodialytic treatment carries a high risk of cluster infection 5,6 . For these reasons, the immunization of hemodialysis patients has been recognized as a public health priority worldwide and a mass vaccination with RNA-platform such as mRNA-1273 vaccine (previously known as vaccine Moderna) has been soon conducted after the release of regulatory agencies' authorization.…”

Section: Introductionmentioning

confidence: 99%

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Morisi

Prof.

Scarmignan

et al. 2021

Preprint

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IntroductionSome hemodialysis patients are reluctant to COVID-19 for the development of adverse events (AEs). The aim of this study was to verify the safety of mRNA-1273 vaccine in hemodialysis patients.MethodsWe conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic.ResultsOverall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥ 65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%).The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population.ConclusionRNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on chronic maintenance hemodialysis. Systemic AEs were more common after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.

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Section: Introductionmentioning

confidence: 99%

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Morisi

Prof.

Scarmignan

et al. 2021

Preprint

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“…Overall results from this study demonstrated that >20% dialysis patients demonstrated an attenuated immune response after receiving SARS-CoV-2 vaccination. Consistent with this finding, and increased risks of severe COVID-19 outcomes, dialysis patients have been recommended for prioritization in being vaccinated against SARS-CoV-2 [ 31 ].…”

Section: Sars-cov-2 Vaccines In Context Of Immunosuppression Therapymentioning

confidence: 81%

Immunosuppression in Glomerular Diseases: Implications for SARS-CoV-2 Vaccines and COVID-19

Yeaman

2021

Glomerular Dis

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Background: Glomerular diseases (GD) are chronic conditions that often involve immune dysfunction and require immunosuppressive therapy (IST) to control underlying pathogenesis. Unfortunately, such diseases appear to heighten risks of severe outcomes in COVID-19 and predispose to other infections that may be life-threatening. Thus, averting preventable infections is imperative in GD patients. Summary: The advent of vaccines demonstrated to be safe and efficacious against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has favorably impacted the COVID-19 pandemic epidemiology. However, patients on ISTs were excluded from initial vaccine clinical trials. Thus, only limited and incomplete data are available currently regarding the potential impact of immunosuppression on immune response to or efficacy of the SARS-CoV-2 vaccines. However, new insights are emerging from SARS-CoV-2 vaccine studies, and impacts of ISTs on conventional vaccines are useful to consider. Mechanisms of immunosuppressive agents commonly used in the treatment of GD are reviewed with respect to implications for immune responses induced by SARS-CoV-2 vaccines. ISTs discussed include corticosteroids; alkylating agents; antimetabolites; calcineurin or mammalian target of rapamycin inhibitors; CD38+, CD20+, or CD19+ cell depletion; and complement protein C5 inhibition. Key Messages: Many immunosuppressive therapies may potentially attenuate or impair protective immunity of the SARS-CoV-2 vaccines. However, as vaccines currently in use employ mRNA or nonreplicative viral vectors, they appear to be safe in patients on immunosuppression, further favoring vaccination. Moreover, predominant SARS-CoV-2 vaccines are likely to afford at least partial protective immunity through one or more immune mechanisms even in patients on IST. Guidelines and emerging strategies are also considered to optimize vaccine protection from COVID-19.

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“…Clinical surveillance protocols at the dialysis organization have been described elsewhere. 9, 10 To summarize, at the time of each clinic visit, all patients undergo a standardized COVID-19 screening. Patients who screen positive for COVID-19 symptoms, or who indicate a recent contact with COVID-19–infected individuals, immediately receive PCR testing.…”

Section: Methodsmentioning

confidence: 99%

“…We previously used this assay for research purposes due to its selectivity for SARS-CoV-2 antibodies and low-levels of cross-reactivity to other coronaviruses or influenza viruses. 9, 10 IgM levels were not measured based on pilot data demonstrating that measured IgM response was implausibly low in this population (<20% positive even in the 28-day period following documented SARS-CoV-2 infection).…”

Section: Methodsmentioning

confidence: 99%

Comparative Effectiveness of BNT162b2 versus Ad26.COV2.S for the Prevention of COVID-19 among Dialysis Patients

Brunelli

Sibbel

Karpinski

et al. 2021

Preprint

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Background: mRNA-based SARS-CoV-2 vaccines have been shown to be highly effective among dialysis patients. Because individual vaccines may be differentially available or acceptable to patients, it is important to understand comparative effectiveness of other vaccines, such those based on adeno-virus technologies. Methods: This retrospective study compared the clinical effectiveness of Ad26.COV2.S (Janssen/Johnson and Johnson) to BNT162b2 among dialysis patients. Patients initiating BNT162b2 (Pfizer/BioNTech) were matched 1:1 to Ad26.COV2.S recipients based on age, race, US state of residence, calendar week of first vaccine receipt, and history of COVID-19. The primary outcome was the comparative rate of COVID-19 considered over 3 follow-up intervals: weeks 1-3, 4-6, and ≥ 7 post-vaccination. In a subset of consented Ad26.COV2.S patients, blood samples were collected ≥28 days after vaccination and anti-SARS-Cov-2 immunoglobulin G antibodies were measured. Results: There were 2659 matched pairs of patients who received a first dose of each vaccine. During weeks 1-3, incidence rates were 1.13 vs 1.39 per 1000 patient-weeks (pt-wks) for BNT162b2 and Ad26.COV2.S recipients, respectively (incident rate difference [IRD]: 0.25; 95% CI: 0.90, 1.36). During weeks 4-6, incidence rates were 0.78 vs 0.39 per 1000 pt-wks for BNT162b2 and Ad26.COV2.S recipients, respectively (IRD: -0.39; 95% CI: -1.16, 0.38). After week 7, incidence rates were 1.29 vs 1.39 per 1000 pt-wks for BNT162b2 and Ad26.COV2.S recipients, respectively (IRD: 0.10; 95% CI: -0.35, 0.55). Results were similar when considering only patients without a history of COVID-19 and among matched pairs in which BNT162b2 recipients completed the 2-dose regimen. SARS-CoV-2 antibodies were detected in 59.4% (95% CI: 53.0%-65.5%) of Ad26.COV2.S patients. Conclusion: In a large real-world cohort of dialysis patients, no difference was detected in the clinical effectiveness of BNT162b2 and Ad26.COV2.S, despite an inconsistent antibody response to the latter. These data support the use of either agent in ongoing vaccination efforts in this population.

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Antibody Status, Disease History, and Incidence of SARS-CoV-2 Infection Among Patients on Chronic Dialysis

Cited by 24 publications

References 10 publications

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Immunosuppression in Glomerular Diseases: Implications for SARS-CoV-2 Vaccines and COVID-19

Comparative Effectiveness of BNT162b2 versus Ad26.COV2.S for the Prevention of COVID-19 among Dialysis Patients

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