Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)

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ClinicalTrials.gov Identifier: NCT04283461

Recruitment Status : Completed

First Posted : February 25, 2020

Last Update Posted : March 8, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

ModernaTX, Inc.

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	April 26, 2022
Actual Study Completion Date :	April 26, 2022

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Anderson E, Jackson L, Rouphael N, Widge A, Montefiori D, Doria-Rose N, Suthar M, Cohen K, O'Connell S, Makowski M, Makhene M, Buchanan W, Spearman P, Creech CB, O'Dell S, Schmidt S, Leav B, Bennett H, Pajon R, Posavad C, Hural J, Beigel J, Albert J, Abebe K, Eaton A, Rostad C, Rebolledo P, Kamidani S, Graciaa D, Coler R, McDermott A, Ledgerwood J, Mascola J, DeRosa S, Neuzil K, McElrath MJ, Roberts P. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 mRNA Vaccine aeuro" An Interim Analysis. Res Sq. 2022 May 3:rs.3.rs-1222037. doi: 10.21203/rs.3.rs-1222037/v1. Preprint.

Jochum S, Kirste I, Hortsch S, Grunert VP, Legault H, Eichenlaub U, Kashlan B, Pajon R. Clinical Utility of Elecsys Anti-SARS-CoV-2 S Assay in COVID-19 Vaccination: An Exploratory Analysis of the mRNA-1273 Phase 1 Trial. Front Immunol. 2022 Jan 19;12:798117. doi: 10.3389/fimmu.2021.798117. eCollection 2021.

Garrett ME, Galloway JG, Wolf C, Logue JK, Franko N, Chu HY, Matsen FA 4th, Overbaugh JM. Comprehensive characterization of the antibody responses to SARS-CoV-2 Spike protein finds additional vaccine-induced epitopes beyond those for mild infection. Elife. 2022 Jan 24;11:e73490. doi: 10.7554/eLife.73490.

Jochum S, Kirste I, Hortsch S, Grunert VP, Legault H, Eichenlaub U, Kashlan B, Pajon R. Clinical utility of Elecsys Anti-SARS-CoV-2 S assay in COVID-19 vaccination: An exploratory analysis of the mRNA-1273 phase 1 trial. medRxiv. 2021 Oct 19:2021.10.04.21264521. doi: 10.1101/2021.10.04.21264521. Preprint.

Mendes BB, Sousa DP, Conniot J, Conde J. Nanomedicine-based strategies to target and modulate the tumor microenvironment. Trends Cancer. 2021 Sep;7(9):847-862. doi: 10.1016/j.trecan.2021.05.001. Epub 2021 Jun 3.

Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438. doi: 10.1056/NEJMoa2028436. Epub 2020 Sep 29.

Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O'Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. N Engl J Med. 2020 Nov 12;383(20):1920-1931. doi: 10.1056/NEJMoa2022483. Epub 2020 Jul 14.

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