Antibody Response After the Third SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients and People Living With HIV (COVERALL-2)
Authors: Griessbach Alexandra , 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 , Epp Selina , Amstutz Alain , Schönenberger Christof M , Taji Heravi Ala , Papadimitriou-Olivgeris Matthaios , Casutt Alessio , Manuel Oriol , Kusejko Katharina , Bucher Heiner C , Briel Matthias , Speich Benjamin ,   the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study, I Abela , K Aebi-Popp , A Anagnostopoulos , M Battegay , E Bernasconi , DL Braun , HC Bucher , A Calmy , M Cavassini , A Ciuffi , G Dollenmaier , M Egger , L Elzi , J Fehr , J Fellay , H Furrer , CA Fux , HF Günthard , A Hachfeld , D Haerry , B Hasse , HH Hirsch , M Hoffmann , I Hösli , M Huber , D Jackson-Perry , CR Kahlert , L Kaiser , O Keiser , T Klimkait , RD Kouyos , H Kovari , K Kusejko , N Labhardt , K Leuzinger , de Tejada B Martinez , C Marzolini , KJ Metzner , N Müller , J Nemeth , D Nicca , J Notter , P Paioni , G Pantaleo , M Perreau , A Rauch , L Salazar-Vizcaya , P Schmid , R Speck , M Stöckle , P Tarr , A Trkola , G Wandeler , M Weisser , S Yerly , Amico Patrizia , Aubert John-David , Banz Vanessa , Beckmann Sonja , Beldi Guido , Berger Christoph , Berishvili Ekaterine , Berzigotti Annalisa , Binet Isabelle , Bochud Pierre-Yves , Branca Sanda , Bucher Heiner , Catana Emmanuelle , Cairoli Anne , Chalandon Yves , De Geest Sabina , De Rougemont Olivier , De Seigneux Sophie , Dickenmann Michael , Dreifuss Joëlle Lynn , Duchosal Michel , Fehr Thomas , Ferrari-Lacraz Sylvie , Garzoni Christian , Golshayan Déla , Goossens Nicolas , Haidar Fadi , Halter Jörg , Heim Dominik , Hess Christoph , Hillinger Sven , Hirsch Hans H , Hirt Patricia , Hoessly Linard , Hofbauer Günther , Huynh-Do Uyen , Immer Franz , Koller Michael , Laesser Bettina , Lamoth Frédéric , Lehmann Roger , Leichtle Alexander , Manuel Oriol , Marti Hans-Peter , Martinelli Michele , McLin Valérie , Mellac Katell , Merçay Aurélia , Mettler Karin , Mueller Nicolas J , Müller-Arndt Ulrike , Müllhaupt Beat , Nägeli Mirjam , Oldani Graziano , Pascual Manuel , Passweg Jakob , Pazeller Rosemarie , Posfay-Barbe Klara , Rick Juliane , Rosselet Anne , Rossi Simona , Rothlin Silvia , Ruschitzka Frank , Schachtner Thomas , Schaub Stefan , Scherrer Alexandra , Schnyder Aurelia , Schuurmans Macé , Schwab Simon , Sengstag Thierry , Simonetta Federico , Stampf Susanne , Steiger Jürg , Stirnimann Guido , Stürzinger Ueli , Van Delden Christian , Venetz Jean-Pierre , Villard Jean , Vionnet Julien , Wick Madeleine , Wilhelm Markus , Yerly Patrick 
Published: November 2023

Abstract

Background
After basic immunization with 2 mRNA SARS-CoV-2 vaccine doses, only a small proportion of patients who are severely immunocompromised generate a sufficient antibody response. Hence, we assessed the additional benefit of a third SARS-CoV-2 vaccine in patients with different levels of immunosuppression.

Methods
In this observational extension of the COVERALL trial (Corona Vaccine Trial Platform), we recruited patients from the Swiss HIV Cohort Study and the Swiss Transplant Cohort Study (ie, lung and kidney transplant recipients). We collected blood samples before and 8 weeks after the third SARS-CoV-2 vaccination with either mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech). The primary outcome was the proportion of participants showing an antibody response (Elecsys Anti-SARS-CoV-2 S test; threshold ≥100 U/mL) 8 weeks after the third SARS-CoV-2 vaccination. We also compared the proportion of patients who reached the primary outcome from basic immunization (the first and second vaccines) to the third vaccination.

Results
Nearly all participants (97.2% [95% CI, 95.9%–98.6%], 564/580) had an antibody response. This response was comparable between mRNA-1273 (96.1% [95% CI, 93.7%–98.6%], 245/255) and BNT162b2 (98.2% [95% CI, 96.7%–99.6%], 319/325). Stratification by cohort showed that 99.8% (502/503) of people living with HIV and 80.5% (62/77) of recipients of solid organ transplants achieved the primary endpoint. The proportion of patients with an antibody response in solid organ transplant recipients improved from the second vaccination (22.7%, 15/66) to the third (80.5%, 62/77).

Conclusions
People living with HIV had a high antibody response. The third vaccine increased the proportion of solid organ transplant recipients with an antibody response.
Clinical Trials Registration. NCT04805125 (ClinicalTrials.gov).