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
Benjamin Speich, Frédérique Chammartin, Irène A. Abela, Patrizia Amico, Marcel Stoeckle, Anna Eichenberger, Barbara Hasse, Dominique L. Braun, Macé M. Schuurmans, Thomas F. Müller, Michael Tamm, Annette Audigé, Nicolas J. Mueller, Andri Rauch, Huldrych F. Günthard, Michael Koller, Alexandra Trkola, Matthias Briel, Katharina Kusejko, Heiner C. Bucher, Swiss HIV Cohort Study and the Swiss Transplant Cohort Study, I A Aebi-Popp, Konstantinos Anagnostopoulos, A Battegay, Michele Bernasconi, Eyal Braun, DorisJ. Bucher, Alexandra Calmy, A Cavassini, M. Ciuffi, A Dollenmaier, Georg Egger, M Elzi, Linda Fehr, Jacques Fellay, Jan Furrer, H Fux, C A Günthard, A Haerry, Betsy Hirsch, H H Hoffmann, M. Hösli, I. Huber, M Kahlert, L. Wayne Keiser, O Klimkait, T Kouyos, R D Kovari, H Kusejko, Begoña Martínez de Tejada, B Marzolini, C Metzner, Kathrin Müller, Norbert Németh, J Nicca, D Paioni, Pietro Pantaleo, G Perreau, Max Philip Rauch, Patricia M. Speck, R Stöckle, P Trkola, Alexander I. Wandeler, G Yerly, Patrizia Amico, Andres Axel, John‐David Aubert, Vanessa Banz, Sonja Beckmann, Guido Beldi, Christoph Berger, Ekaterine Berishvili, Isabelle Binet, Pierre–Yves Bochud, Sanda Branca, Heiner C Bucher, Thierry Carrel, Emmanuelle Catana, Yves Chalandon, Sabina De Geest, Olivier de Rougemont, Michael Dickenmann, Joëlle Lynn Dreifuss, Michel A. Duchosal, Thomas Fehr, Sylvie Ferrari-Lacraz, Nicola Franscini, Christian Garzoni, Paola Gasche Soccal, Christophe Gaudet, Déla Golshayan, Nicolas Goossens, Karine Hadaya, Jörg Halter, Dominik Heim, Christoph Hess, Sven Hillinger, Hans H. Hirsch, Patricia Hirt, Günther F.L. Hofbauer
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.