@article{78625011b60842ec9bd4cef4be27b467,
title = "The risk and consequences of breakthrough SARS-CoV-2 infection in solid organ transplant recipients relative to non-immunosuppressed controls",
abstract = "Clinical outcomes in solid organ transplant (SOT) recipients with breakthrough COVID (BTCo) after two doses of mRNA vaccination compared to the non-immunocompromised/immunosuppressed (ISC) general population, are not well described. In a cohort of adult patients testing positive for COVID-19 between December 10, 2020 and April 4, 2022, we compared the cumulative incidence of BTCo in a non-ISC population to SOT recipients (overall and by organ type) using the National COVID Cohort Collaborative (N3C) including data from 36 sites across the United States. We assessed the risk of complications post-BTCo in vaccinated SOT recipients versus SOT with unconfirmed vaccination status (UVS) using multivariable Cox proportional hazards and logistic regression. BTCo occurred in 4776 vaccinated SOT recipients over a median of 149 days (IQR 99–233), with the highest cumulative incidence in heart recipients. The relative risk of BTCo was greatest in SOT recipients (relative to non-ISC) during the pre-Delta period (HR 2.35, 95% CI 1.80–3.08). The greatest relative benefit with vaccination for both non-ISC and SOT cohorts was in BTCo mortality (HR 0.37, 95% CI 0.36–0.39 for non-ISC; HR 0.67, 95% 0.57–0.78 for SOT relative to UVS). While the relative benefit of vaccine was less in SOT than non-ISC, SOT patients still exhibited significant benefit with vaccination.",
keywords = "COVID-19, MACE, MARCE, SARS-CoV-2, allograft type, breakthrough, cardiac, heart, infection, kidney, liver, lung, mortality, outcome, solid organ transplantation, vaccination",
author = "{N3C Consortium} and Vinson, {Amanda J.} and Anzalone, {Alfred J.} and Jing Sun and Ran Dai and Gaurav Agarwal and Lee, {Stephen B.} and Evan French and Amy Olex and Ison, {Michael G.} and Mannon, {Roslyn B.}",
note = "Funding Information: We acknowledge support from many grants; the content is solely the responsibility of the authors and does not necessarily represent the official views of the N3C Program, the NIH or other funders. In addition, access to N3C Data Enclave resources does not imply endorsement of the research project and/or results by NIH or NCATS. Funding Information: The authors of this manuscript have conflicts of interest to disclose as described by the . AV has done consultancy work and received funding for a fellowship project grant through Paladin Labs Inc. AG has received educational funds from Mallinckrodt Pharmaceuticals and has served as PI for studies by Mallinckrodt Pharmaceuticals and CSL Behring. RBM reports grant funding from VericiDX, honoraria from Olaris Inc, personal fees from Vitaerris as member of the IMAGINE Trial Steering committee, and personal fees from as Deputy Editor of the journal, outside the submitted work. MGI reports research support, paid to Northwestern University, from AiCuris, GlaxoSmithKline, Janssen, and Shire; he is a paid consultant for Adagio, AlloVir, Celltrion, Cidara, Genentech, Roche, Janssen, Shionogi, and Viracor Eurofins; he is also a paid member of DSMBs from Janssen, Merck, SAB Biotherapeutics, Sequiris, Takeda, and Vitaeris; he also receives royalties from UpToDate. MGI is supported, in part, by NCATS grant UL1TR001422. American Journal of Transplantation American Journal of Transplantation Funding Information: AO and EF were supported by CTSA award No. UL1TR002649 from the National Center for Advancing Translational Sciences. AJA was supported by U54GM104942‐05S2 and U54GM115458 from the National Institute of General Medical Sciences, which funds the West Virginia Clinical & Translational Science Institute and the Great Plains IDeA Clinical & Translational Research Network. The analyses described in this publication were conducted with data or tools accessed through the NCATS N3C Data Enclave https://covid.cd2h.org and N3C Attribution and Publication Policy v 1.2‐2020‐08‐25b supported by NCATS U24 TR002306. RBM is supported by BMX003272 and the Dr. Dennis Ross Research Fund in Nephrology, University of Nebraska. Publisher Copyright: {\textcopyright} 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.",
year = "2022",
month = oct,
doi = "10.1111/ajt.17117",
language = "English (US)",
volume = "22",
pages = "2418--2432",
journal = "American Journal of Transplantation",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "10",
}