Lyke, Kirsten E. http://orcid.org/0000-0002-4966-0830
Atmar, Robert L. http://orcid.org/0000-0001-9989-6772
Dominguez Islas, Clara
Posavad, Christine M.
Deming, Meagan E. http://orcid.org/0000-0003-2574-0542
Branche, Angela R.
Johnston, Christine http://orcid.org/0000-0002-3073-0843
El Sahly, Hana M.
Edupuganti, Srilatha
Mulligan, Mark J.
Jackson, Lisa A.
Rupp, Richard E.
Rostad, Christina A.
Coler, Rhea N.
Bäcker, Martín
Kottkamp, Angelica C. http://orcid.org/0000-0003-4103-1666
Babu, Tara M. http://orcid.org/0000-0001-7093-4077
Dobrzynski, David http://orcid.org/0000-0001-5652-7432
Martin, Judith M. http://orcid.org/0000-0001-9456-1770
Brady, Rebecca C.
Frenck, Robert W. Jr.
Rajakumar, Kumaravel
Kotloff, Karen http://orcid.org/0000-0003-1808-6431
Rouphael, Nadine
Szydlo, Daniel
PaulChoudhury, Rahul
Archer, Janet I.
Crandon, Sonja
Ingersoll, Brian
Eaton, Amanda http://orcid.org/0000-0003-3064-2947
Brown, Elizabeth R.
McElrath, M. Juliana
Neuzil, Kathleen M.
Stephens, David S.
Post, Diane J. http://orcid.org/0000-0003-3890-9116
Lin, Bob C.
Serebryannyy, Leonid
Beigel, John H. http://orcid.org/0000-0002-4879-4941
Montefiori, David C.
Roberts, Paul C. http://orcid.org/0000-0002-4452-141X
Anderson, Evan J.
Berman, Megan
Cohen, Kristen W.
De Rosa, Stephen
Dickey, Michelle
Dong, Jennifer Lee
Ellis, Madison
Falsey, Ann R.
Fleming, Andrew B.
Floyd, Katharine
Foster, Stephanie L.
Graciaa, Daniel
Kahn, Ahsen
Kamidani, Satoshi
Keitel, Wendy A.
Lai, Lilin
Larsen, Sasha E.
Lee, Marina
Manning, Kelly
Moore, Kathryn M.
Mulholland, Vivian
Muniz, Gysella B.
Nayak, Seema
Noor, Asif
Patel, Mit
Porterfield, Laura
Price, Angie
Shannon, Ian
Shope, Timothy R.
Stanford, Amber
Suthar, Mehul S.
Wald, Anna
Whitaker, Jennifer A.
,
Funding for this research was provided by:
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Article History
Received: 9 March 2023
Accepted: 9 June 2023
First Online: 11 July 2023
Competing interests
: R.L.A., C.P.D.I., C.M.P., D.S., R.P., M.E.D., A.E., H.M.E., M.B., A.C.K., T.M.B., D.D., J.L.A., B.I., S.C., E.R.B., D.J.P., B.C.L., and L.S. declare no competing interests. K.E.L. receives grant awards from Pfizer Inc. (exclusive of the current work). L.A.J.’s institution receives grant funding from NIH, CDC, and Pfizer for vaccine-related assessments, including those of COVID-19 vaccines. R.E.R. serves as an Editor for the journal NPJ Vaccines. A.R.B. has grant funding from Pfizer, Janssen, Merck and Cyanvac for non-COVID-19-related work and serves as a consultant for GSK and Janssen. C.A.R.’s institution has received funds to conduct clinical research from the National Institutes of Health, CDC, BioFire Inc, Genentech, GSK, Janssen, MedImmune, Merck, Micron, Moderna, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur. She is co-inventor of patented RSV vaccine technology, which has been licensed to Meissa Vaccines, Inc. J.M.M. has served as a consultant for Merck, Sharp and Dohme for non-Covid-related work. C.J. receives funding from the Bill and Melinda Gates Foundation, N.I.H. and C.D.C., consults for Gilead, Abbvie, Assembly Biosciences and GSK, and receives royalties from UpToDate. M.J.M. has laboratory research and clinical trials contracts for vaccines or MAB vs SARS-CoV-2 with Lilly, Pfizer (exclusive of the current work), and Sanofi; personal fees for Scientific Advisory Board service from Merck, Meissa Vaccines, Inc. and Pfizer. R.N.C. has funding from Cyanvac and HDT Bio to conduct COVID-19-related clinical immunology research. R.C.B. receives funding for vaccine trials from Path Nipah and Pfizer. R.W.F. receives funding to perform clinical trials from Pfizer, Moderna, Astra Zeneca and Emergent Health, and he serves on advisory boards for Johnson & Johnson, Merck, Sanofi Pasteur and Seqirus. S.E. receives funding to her institution from Sanofi Pasteur for a non-COVID-19 vaccine study. K.M.N. holds a grant from Pfizer, without salary support, for a COVID-19 vaccine study, and salary support from the National Institutes of Health (NIH) for work on multiple COVID-19 vaccine trials. D.S.S. is supported by grant awards from NIH/NIAID. P.C.R. and J.H.B. report a pending U.S. Patent Application No. 63/025,918 entitled “Coronavirus RNA vaccines and methods of use”. D.C.M. receives funding from NIH and Moderna for laboratory studies of COVID-19 vaccine antibody responses. We would like to acknowledge Moderna, Inc., Johnson & Johnson/Janssen, and Pfizer/BioNTech Pharmaceuticals for their collaboration, scientific input, and sharing of documents needed to implement this trial. All products were acquired through the government procurement process. All other authors declare no financial or non-financial competing interests.
: Research was conducted in accordance with the Declaration of Helsinki. The trial (NIH/NIAID/DMID – 21-0012; Pro00053376) was reviewed and approved by a central institutional review board, Advarra (Columbia, MD), and overseen by an independent safety monitoring committee. The clinical trial was performed in sequential stages at ten U.S. clinical sites with individual Reliance Agreements with the Central IRB. Written informed consent was obtained from participants prior to screening and study procedures. All methods were performed in accordance with the relevant guidelines and regulations.