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Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

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We thank the volunteers who participated in the COVE trial. We also thank J. Mascola, M. Hepburn, R. A. Johnson, M. Marovich, and M. Robb. Funding: Public Health Service, National Institute of Allergy and Infectious Diseases, National Institutes of Health grant UM1AI068635 (PBG). Office of Research Infrastructure Programs (ORIP), National Institutes of Health grant (S10OD028685) (Fred Hutchinson Cancer Research Center). Moderna, Inc. Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Contract No. 75A50120C00034 (Moderna, Inc.). Infectious Disease Clinical Research Consortium (IDCRC) Leadership Group through the National Institute for Allergy and Infectious Diseases, grant UM1 AI148684-03 (KMN). Author contributions: Conceptualization: PBG, DCM, ABM, YF, DB, DF, ROD, RAK. Data curation: PBG, YF, DB, WD, HZ, YL, CY, BB, LvdL, NH. Formal analysis: PBG, YF, DB, YL, CY, BB, LvdL, NH. Funding acquisition: PBG, ROD, RAK. Investigation: DCM, ABM, KM, LJ, FC, BF, BCL, SOC, CM, AE, MS-K. Methodology: PBG, YF, DB, LvdL, DF. Project administration: CRH, SOC, MS-K, CH, ROD, RAK. Resources: DCM, ABM, JM, HMES, LRB, BM, LDLC, CG, SK, CFK, MPA, JGK, LC, KMN, RP, ROD, RAK. Software: PBG, YF, DB, YL, CY, BB, LvdL, NH. Supervision: PBG, DCM, ABM, YF, DB, DF, ROD, RAK. Validation: PBG, YF, DB. Visualization: PBG, YF, DB, YL, BB, LvdL, LNC. Writing – original draft: PBG, LNC. Writing – review and editing: All co-authors. Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/downloads/coi_disclosure.docx and declare: PBG, DCM, YF, CM, AE, MS-K, YL, CY, BB, LvdL, HMES, LRB, MB, CFK, MPA, LC, and LNC had support (in the form of grant payments to their institution) from the National Institutes of Health for the submitted work; RAK had support (in the form of funds to the VRC to cover assay performance) from the National Institutes of Health for the submitted work; MB, LDLC, and CFK had support (in the form of payments to their institution) from Moderna for the submitted work; WD, HZ, JM, and RP are employed by Moderna Tx, Inc. and have stock and/or stock options in Moderna Tx, Inc.; LRB declares support (in the form of grant payments to his institution) within the previous three years from the National Institutes of Health, the Wellcome Trust, and the Bill and Melinda Gates Foundation and has served on NIAID-NIH SMCs within the previous three years; MB declares support (in the form of grant payments to her institution) within the previous three years from the National Institutes of Health and the Centers for Disease Control; CFK declares support (in the form of grant payments to her institution) within the previous three years from the National Institutes of Health, the Centers for Disease Control, Humanigen, Novavax, Viiv, and Gilead, as well as payments from Medscape and from Clinical Care Options within the previous three years for educational events; KMN declares support (in the form of grant payments to her institution) within the previous three years from GSK, Pfizer, Bill & Melinda Gates Foundation, and PATH for vaccine research, as well as support (in the form of grant payments to her institution) within the previous three years from the National Institutes of Health for influenza vaccine research; and DCM declares support from Moderna within the previous three years for work outside the scope of the submitted work. All other authors declare no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. Data and materials availability: As the trial is ongoing, access to participant-level data and supporting clinical documents with qualified external researchers may be available upon request and subject to review once the trial is complete. The code is publicly available at Zenodo (38). This work is licensed under a Creative Commons Attribution 4.0 International (CC BY 4.0) license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/. This license does not apply to figures/photos/artwork or other content included in the article that is credited to a third party; obtain authorization from the rights holder before using such material.

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