Antibody Response in Immunocompromised Patients After the Administration of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine BNT162b2 or mRNA-1273: A Randomized Controlled Trial
Author:
Speich Benjamin12, Chammartin Frédérique1, Abela Irene A34, Amico Patrizia5, Stoeckle Marcel P6, Eichenberger Anna L7, Hasse Barbara4, Braun Dominique L34, Schuurmans Macé M8, Müller Thomas F9, Tamm Michael10, Audigé Annette3, Mueller Nicolas J4, Rauch Andri7, Günthard Huldrych F34, Koller Michael T11, Trkola Alexandra3, Briel Matthias112, Kusejko Katharina34, Bucher Heiner C1, Aebi-Popp I A, Anagnostopoulos K, Battegay A, Bernasconi M, Braun E, Bucher D L, Calmy H C, Cavassini A, Ciuffi M, Dollenmaier A, Egger G, Elzi M, Fehr L, Fellay J, Furrer J, Fux H, Günthard C A, Haerry A, Hirsch B, Hoffmann H H, Hösli M, Huber I, Kahlert M, Keiser L, Klimkait O, Kouyos T, Kovari R D, Kusejko H, Martinez de Tejada G, Marzolini B, Metzner C, Müller K J, Nemeth N, Nicca J, Paioni D, Pantaleo P, Perreau G, Rauch M, Speck P, Stöckle R, Trkola P, Wandeler A, Yerly G, Amico Patrizia, Axel Andres, Aubert John David, Banz Vanessa, Sonja Beckmann, Beldi Guido, Berger Christoph, Berishvili Ekaterine, Binet Isabelle, Bochud Pierre Yves, Branca Sanda, Bucher Heiner C, Carrel Thierry, Catana Emmanuelle, Chalandon Yves, De Geest Sabina, De Rougemont Olivier, Dickenmann Michael, Dreifuss Joëlle Lynn, Duchosal Michel, Fehr Thomas, Ferrari-Lacraz Sylvie, Franscini Nicola, Garzoni Christian, Soccal Paola Gasche, Gaudet Christophe, Golshayan Déla, Goossens Nicolas, Hadaya Karine, Halter Jörg, Heim Dominik, Hess Christoph, Hillinger Sven, Hirsch Hans, Hirt Patricia, Hofbauer Günther, Huynh-Do Uyen, Immer Franz, Koller Michael, Laager Mirjam, Laesser Bettina, Lehmann Roger, Leichtle Alexander, Lovis Christian, Manuel Oriol, Marti Hans Peter, Martin Pierre Yves, Martinelli Michele, McLin Valérie, Mellac Katell, Merçay Aurélia, Mettler Karin, Mueller Nicolas, Müller Antonia, Müller-Arndt Ulrike, Müllhaupt Beat, Nägeli Mirjam, Oldani Graziano, Pascual Manuel, Posfay-Barbe Klara, Rick Juliane, Rosselet Anne, Rossi Simona, Rothlin Silvia, Ruschitzka Frank, Schachtner Thomas, Schanz Urs, Schaub Stefan, Schnyder Aurelia, Schuurmans Macé, Sengstag Thierry, Simonetta Federico, Stampf Susanne, Steiger Jürg, Stirniman Guido, Stürzinger Ueli, Van Delden Christian, Venetz Jean Pierre, Villard Jean, Vionnet Julien, Wick Madeleine, Wilhlem Markus, Yerly Patrick,
Affiliation:
1. Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel , Basel , Switzerland 2. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford , Oxford , United Kingdom 3. University of Zurich, Institute of Medical Virology , Zurich , Switzerland 4. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich , Zurich , Switzerland 5. Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, University of Basel , Basel , Switzerland 6. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel , Switzerland 7. Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern , Bern , Switzerland 8. Division of Pulmonology, University Hospital Zurich , Zurich , Switzerland 9. Nephrology Clinic, University Hospital Zurich , Zürich , Switzerland 10. Clinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, University of Basel , Basel , Switzerland 11. Swiss Transplant Cohorts Study, University Hospital Basel, University of Basel , Basel , Switzerland and 12. Department of Health Research Methods, Evidence, and Impact, McMaster University , Hamilton , Canada
Abstract
Abstract
Background
BNT162b2 by Pfizer-BioNTech and mRNA-1273 by Moderna are the most commonly used vaccines to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Head-to-head comparison of the efficacy of these vaccines in immunocompromised patients is lacking.
Methods
Parallel, 2-arm (allocation 1:1), open-label, noninferiority randomized clinical trial nested into the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study. People living with human immunodeficiency virus (PLWH) or solid organ transplant recipients (SOTR; ie, lung and kidney) from these cohorts were randomized to mRNA-1273 or BNT162b2. The primary endpoint was antibody response to SARS-CoV-2 spike (S1) protein receptor binding domain (Elecsys Anti-SARS-CoV-2 immunoassay, Roche; cutoff ≥0.8 units/mL) 12 weeks after first vaccination (ie, 8 weeks after second vaccination). In addition, antibody response was measured with the Antibody Coronavirus Assay 2 (ABCORA 2).
Results
A total of 430 patients were randomized and 412 were included in the intention-to-treat analysis (341 PLWH and 71 SOTR). The percentage of patients showing an immune response was 92.1% (95% confidence interval [CI]: 88.4–95.8; 186/202) for mRNA-1273 and 94.3% (95% CI: 91.2–97.4; 198/210) for BNT162b2 (difference: -2.2%; 95% CI: -7.1 to 2.7), fulfilling noninferiority of mRNA-1273. With the ABCORA 2 test, 89.1% had an immune response to mRNA-1273 (95% CI: 84.8–93.4; 180/202) and 89.5% to BNT162b2 (95% CI: 85.4–93.7; 188/210). Based on the Elecsys test, all PLWH had an antibody response (100.0%; 341/341), whereas for SOTR, only 60.6% (95% CI: 49.2–71.9; 43/71) had titers above the cutoff level.
Conclusions
In immunocompromised patients, the antibody response of mRNA-1273 was noninferior to BNT162b2. PLWH had in general an antibody response, whereas a high proportion of SOTR had no antibody response.
Funder
Swiss National Science Foundation Swiss Transplant Cohort Study University of Zurich Foundation Promedica Foundation
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Cited by
29 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
|
|