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Immunocompromised individuals have been excluded from studies of SARS-CoV-2 messenger RNA (mRNA) vaccines. In such patients, the immune response to vaccination may be blunted. To better understand the immunogenicity of mRNA vaccines in immunocompromised individuals, we quantified the humoral response to the first dose in solid organ transplant recipients.
Transplant recipients across the US were recruited though social media to participate in this prospective cohort, and those who underwent SARS-CoV-2 vaccination between December 16, 2020, and February 5, 2021, were included. The study was approved by the Johns Hopkins University institutional review board and participants provided informed consent electronically. Participants underwent either at-home blood sampling with the TAPII blood collection device (Seventh Sense Biosystems) or standard venipuncture.
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Accepted for Publication: March 8, 2021.
Published Online: March 15, 2021. doi:10.1001/jama.2021.4385
Corresponding Author: Dorry L. Segev, MD, PhD, Department of Surgery, Johns Hopkins University Medical Institutions, 2000 E Monument St, Baltimore, MD 21205 (firstname.lastname@example.org).
Author Contributions: Drs Segev and Garonzik-Wang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Boyarsky, Werbel, Avery, Massie, Segev, Garonzik-Wang.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Boyarsky, Massie, Segev.
Administrative, technical, or material support: Boyarsky, Tobian, Segev, Garonzik-Wang.
Supervision: Massie, Segev, Garonzik-Wang.
Conflict of Interest Disclosures: Dr Avery reported receiving grant support from Aicuris, Astellas, Chimerix, Merck, Oxford Immunotec, Qiagen, and Takeda/Shire. Dr Segev reported serving as a consultant to and receiving honoraria for speaking from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. No other disclosures were reported.
Funding/Support: This work was supported by the Ben-Dov family; grants F32DK124941 (awarded to Dr Boyarsky), K01DK101677 (to Dr Massie), and K23DK115908 (to Dr Garonzik-Wang) from the National Institute of Diabetes and Digestive and Kidney Diseases; grant gSAN-201C0WW (to Dr Werbel) from the Transplantation and Immunology Research Network of the American Society of Transplantation; and grant K24AI144954 (to Dr Segev) from the National Institute of Allergy and Infectious Diseases.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The analyses described are the responsibility of the authors and do not necessarily reflect the views or policies of the US Department of Health and Human Services. The mention of trade names, commercial products, or organizations does not imply endorsement by the US government.
Additional Contributions: We acknowledge the following individuals for their assistance with this study, none of whom was compensated for his or her contributions: Oliver B. Laeyendecker, PhD, Yukari C. Manabe, MD, Christine M. Durand, MD, Caoilfhionn M. Connolly, MD, and Julie J. Paik, MD, MHS (all 5 for analysis and affiliated with the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland); William A. Clarke, PhD, and Patrizio P. Caturegli, MD, MPH (both for analysis and affiliated with the Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland); Aaron M. Milstone, MD, MHS (data collection and analysis), and Ani Voskertchian, MPH (data collection) (both affiliated with the Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland); and Sunjae Bae, MD, PhD (analysis), Michael T. Ou, BS (data collection and writing/editing assistance), and Richard Wang, BA, Aura T. Teles, BS, Ross S. Greenberg, BA, Jake A. Ruddy, BS, Leyla R. Herbst, BA, Michelle R. Krach, MS, Michael D. Irving, BA, Kayleigh M. Herrick-Reynolds, MD, Mackenzie A. Eagleson, MD, Andrew M. Hallett, MD, and Victoria A. Bendersky, MD (11 for data collection) (all 13 affiliated with the Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland).
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