Humoral and cellular immunity to SARS-CoV-2 vaccination in renal transplant versus dialysis patients: A prospective, multicenter observational study using mRNA-1273 or BNT162b2 mRNA vaccine

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Abstract

Background

Dialysis and kidney transplant patients are vulnerable populations for COVID-19 related disease and mortality.

Methods

We conducted a prospective study exploring the eight week time course of specific cellular (interferon-γ release assay and flow cytometry) or/and humoral immune responses (ELISA) to SARS-CoV-2 boost vaccination in more than 3100 participants including medical personnel, dialysis patients and kidney transplant recipients using mRNA vaccines BNT162b2 or mRNA-1273.

Results

SARS-CoV-2-vaccination induced seroconversion efficacy in dialysis patients was similar to medical personnel (> 95%), but markedly impaired in kidney transplant recipients (42%). T-cellular immunity largely mimicked humoral results. Major risk factors of seroconversion failure were immunosuppressive drug number and type (belatacept, MMF-MPA, calcineurin-inhibitors) as well as vaccine type (BNT162b2 mRNA). Seroconversion rates induced by mRNA-1273 compared to BNT162b2 vaccine were 97% to 88% ( p < 0.001) in dialysis and 49% to 26% in transplant patients, respectively. Specific IgG directed against the new binding domain of the spike protein (RDB) were significantly higher in dialysis patients vaccinated by mRNA-1273 (95%) compared to BNT162b2 (85%, p < 0.001). Vaccination appeared safe and highly effective demonstrating an almost complete lack of symptomatic COVID-19 disease after boost vaccination as well as ceased disease incidences during third pandemic wave in dialysis patients.

Conclusion

Dialysis patients exhibit a remarkably high seroconversion rate of 95% after boost vaccination, while humoral response is impaired in the majority of transplant recipients. Immunosuppressive drug number and type as well as vaccine type (BNT162b2) are major determinants of seroconversion failure in both dialysis and transplant patients suggesting immune monitoring and adaption of vaccination protocols.

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Most cited references 30

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)

Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)

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Regularization Paths for Generalized Linear Models via Coordinate Descent

Jerome H. Friedman, Trevor J. Hastie, Robert Tibshirani … (2011)

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Author and article information

Journal

Journal ID (nlm-ta): Lancet Reg Health Eur

Journal ID (iso-abbrev): Lancet Reg Health Eur

Title: The Lancet Regional Health. Europe

Publisher: The Authors. Published by Elsevier Ltd.

ISSN (Electronic): 2666-7762

Publication date PMC-release: 23 July 2021

Publication date (Electronic): 23 July 2021

Electronic Location Identifier: 100178

Affiliations

[a ]Medizinische Klinik und Poliklinik III, Universitätsklinikum, Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

[b ]KfH-Nierenzentrum am Klinikum Chemnitz, Krankenhaus Küchwald, Chemnitz, Germany

[c ]Division of Nephrology, University Hospital Leipzig, Leipzig, Germany

[d ]KfH-Nierenzentrum am Klinikum St. Georg, Leipzig, Germany

[e ]Dialysezenturm Chemnitz, Chemnitz, Germany

[f ]Dialysepraxis Leipzig, Leipzig, Germany

[g ]Nephrologisches Zentrum Freiberg, Freiberg, Germany

[h ]Dialyse- und Nierenambulanz Sebnitz, Sebnitz, Germany

[i ]Nephrologisches Zentrum Zwickau, Zwickau, Germany

[j ]PHV Dialysezentrum Dresden Friedrichstadt, Dresden, Germany

[k ]Dialyse Heidenau, Heidenau, Germany

[l ]Nephrocare GmbH Döbeln, Döbeln, Germany

[m ]PHV Dialysezentrum Dresden-Johannstadt, Dresden, Germany

[n ]Dialysezentrum Annaberg, Annaberg-Buchholz, Germany

[o ]KfH-Nierenzentrum Grimma, Grimma, Germany

[p ]KfH-Nierenzentrum Bischofswerda, Bischofswerda, Germany

[q ]KfH-Nierenzentrum am Städtischen Klinikum Görlitz, Görlitz, Germany

[r ]KfH-Nierenzentrum Bautzen, Bautzen, Germany

[s ]Via medis Nierenzentrum Dresden MVZ GmbH, Dresden, Germany

[t ]KfH-Gesundheitszentrum Aue, Aue-Bad-Schlema, Germany

[u ]ELBLAND Dialyse Großenhain, Großenhain, Germany

[v ]Dialyse-Praxis Weißwasser, Weißwasser, Germany

[w ]Nephrologisches Zentrum Hoyerswerda, Hoyerswerda, Germany

[x ]KfH-Nierenzentrum am Vogtland Krankenhaus Plauen, Plauen, Germany

[y ]Department of Nephrology und Rheumatology, Internal Medicine II, Martin-Luther-University Halle/Wittenberg, Halle, Germany

[z ]Institut für Transfusionsmedizin Plauen, DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH, Plauen, Germany

[aa ]National Center for Tumor Diseases (NCT) Partner Site Dresden, Dresden, Germany

[ab ]Faculty of Medicine Carl Gustav Carus, Institute for Medical Informatics and Biometry (IMB), Technische Universität, Dresden, Germany

[ac ]Coordinating Centre for Clinical Trials, Dresden, Germany

[ad ]Center for Translational Medicine and Immune Diagnostics Laboratory, Medical Department I, Marien Hospital Herne, University Hospital of the Ruhr-University Bochum, Germany

[ae ]Medical Department I, Marien Hospital Herne, University Hospital of the Ruhr-University Bochum, Herne, Germany

[af ]Institute for Transfusion Medicine, German Red Cross Blood Donation Service North-East, Dresden, Germany

[ag ]Faculty of Medicine Carl Gustav Carus, Transfusion Medicine, Technische Universität, Dresden, Germany

[ah ]Berlin-Brandenburg Center for Regenerative Therapies, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, and Institute of Medical Immunology, Germany

[ai ]KfH-Nierenzentrum Dresden, Dresden, Germany

Author notes

[* ] Corresponding author at: Prof. Dr. med. Christian HugoDivision of Nephrology Department of Internal Medicine III University Hospital Carl Gustav Carus of the Technische Universität Dresden01307 Dresden Germany.

[1]

These authors contributed equally to this work.

Article

Publisher Item ID: S2666-7762(21)00155-1 Publisher ID: 100178

DOI: 10.1016/j.lanepe.2021.100178

PMC ID: 8299287

PubMed ID: 34318288

SO-VID: 36eda189-6b12-4055-a2e0-f8e03070a978

License:

Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

Humoral and cellular immunity to SARS-CoV-2 vaccination in renal transplant versus dialysis patients: A prospective, multicenter observational study using mRNA-1273 or BNT162b2 mRNA vaccine

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Abstract

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Novel Coronavirus Disease COVID-19

Most cited references 30

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Regularization Paths for Generalized Linear Models via Coordinate Descent

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