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
Authors: Speich Benjamin , Chammartin Frédérique , Abela Irene A , Amico Patrizia , Stoeckle Marcel P , Eichenberger Anna L , Hasse Barbara , Braun Dominique L , Schuurmans Macé M , Müller Thomas F , Tamm Michael , Audigé Annette , Mueller Nicolas J , Rauch Andri , Günthard Huldrych F , Koller Michael T , Trkola Alexandra , Briel Matthias , Kusejko Katharina , Bucher Heiner C ,   Swiss HIV Cohort Study and the Swiss Transplant Cohort Study, 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 
Published: March 2022

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.