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.

Autor:	Speich B; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom., Chammartin F; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland., Abela IA; University of Zurich, Institute of Medical Virology, Zurich, Switzerland.; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Amico P; Clinic for Transplantation Immunology and Nephrology, University Hospital Basel, University of Basel, Basel, Switzerland., Stoeckle MP; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, University of Basel, Switzerland., Eichenberger AL; Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Hasse B; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Braun DL; University of Zurich, Institute of Medical Virology, Zurich, Switzerland.; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Schuurmans MM; Division of Pulmonology, University Hospital Zurich, Zurich, Switzerland., Müller TF; Nephrology Clinic, University Hospital Zurich, Zürich, Switzerland., Tamm M; Clinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, University of Basel, Basel, Switzerland., Audigé A; University of Zurich, Institute of Medical Virology, Zurich, Switzerland., Mueller NJ; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Rauch A; Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Günthard HF; University of Zurich, Institute of Medical Virology, Zurich, Switzerland.; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Koller MT; Swiss Transplant Cohorts Study, University Hospital Basel, University of Basel, Basel, Switzerlandand., Trkola A; University of Zurich, Institute of Medical Virology, Zurich, Switzerland., Briel M; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada., Kusejko K; University of Zurich, Institute of Medical Virology, Zurich, Switzerland.; Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland., Bucher HC; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2022 Aug 24; Vol. 75 (1), pp. e585-e593.
DOI:	10.1093/cid/ciac169
Abstrakt:	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. (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America.)
Databáze:	MEDLINE
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