Corresponding Author: Dan H. Barouch, MD, PhD, Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, 330 Brookline Ave, E/CLS-1043, Boston, MA 02215 (dbarouch@bidmc.harvard.edu).
Accepted for Publication: February 25, 2021.
Published Online: March 11, 2021. doi:10.1001/jama.2021.3645
Author Contributions: Dr Barouch had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Stephenson, Le Gars, Sadoff, de Groot, Truyers, Jaegle, Struyf, Douoguih, Van Hoof, Schuitemaker, Barouch.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Stephenson, Yu, Li, Jaegle, Kanjilal, Schuitemaker, Barouch.
Critical revision of the manuscript for important intellectual content: Stephenson, Le Gars, Sadoff, de Groot, Heerwegh, Truyers, Atyeo, Loos, Chandrashekar, McMahan, Tostanoski, Gebre, Jacob-Dolan, Patel, Peter, Liu, Borducchi, Nkolola, Souza, Tan, Zash, Julg, Nathavitharana, Shapiro, Abdul Azim, Alonso, Ansel, Guiney, Bradshaw, Tyler, Makoni, Yanosick, Seaman, Lauffenburger, Alter, Struyf, Douoguih, Van Hoof, Schuitemaker, Barouch.
Statistical analysis: Stephenson, Le Gars, Heerwegh, Truyers, Loos, Tostanoski.
Obtained funding: Stephenson, Barouch.
Administrative, technical, or material support: Stephenson, Le Gars, Sadoff, de Groot, Chandrashekar, McMahan, Gebre, Patel, Peter, Liu, Borducchi, Souza, Tan, Julg, Nathavitharana, Abdul Azim, Alonso, Ansel, Kanjilal, Guiney, Bradshaw, Tyler, Makoni, Yanosick, Seaman, Alter.
Supervision: Stephenson, Chandrashekar, Nkolola, Souza, Tan, Julg, Jaegle, Ansel, Lauffenburger, Alter, Struyf, Douoguih, Van Hoof, Schuitemaker, Barouch.
Conflict of Interest Disclosures: Dr Stephenson reported receiving grants from the National Institutes of Health (NIH), Gilead, and Regeneron during the conduct of the study. Dr Le Gars reported receiving grants from the Biomedical Advanced Research and Development Authority (BARDA) during the conduct of the study, being an employee of Janssen Pharmaceuticals, and being a coinventor on related vaccine patents. Dr Sadoff reported receiving grants from BARDA , being an employee of Janssen, and having a patent for a COVID-19 vaccine pending, assigned to Janssen. Dr de Groot reported receiving grants from BARDA during the conduct of the study, being an employee of Janssen Infectious Diseases and Vaccines, and being coinventor on related vaccine patents. Dr Heerwegh reported receiving grants from Janssen Vaccines & Prevention during the conduct of the study; receiving personal fees from Janssen Vaccines & Prevention and restricted shares from Janssen Vaccines & Prevention outside the submitted work; and being coinventor on related vaccine patents. Dr Truyers reported receiving grants from BARDA for Ad26 COVID-19 vaccine development and being an employee of Johnson & Johnson. Dr Nkolola reported receiving contracted assignments from Janssen Vaccines & Prevention BV and grants from the Massachusetts Consortium on Pathogen Readiness (MassCPR), the NIH, and BARDA during the conduct of the study. Dr Alonso reported receiving grants from Merck during the conduct of the study. Dr Alter reported being cofounder and consultant of Seromyx Systems Inc; receiving grants from Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, Merck, Gilead, Novavax, Janssen, Sanofi, and the Bill and Melinda Gates Foundation outside the submitted work; and having a patent for Systems Serology Platform pending. Dr Struyf reported receiving grants from Janssen R&D during the conduct of the study ,being an employee of Janssen R&D, and being coinventor on related vaccine patents. Dr Douoguih reported receiving grants from BARDA during the conduct of the study, being an employee of Janssen, receiving company stocks outside the submitted work, and being coinventor on related vaccine patents. Dr Van Hoof reported being an employee of Janssen Pharmaceuticals and coinventor on related vaccine patents. Dr Schuitemaker reported receiving grants from BARDA during the conduct of the study, receiving personal fees from Janssen Vaccines & Prevention BV and Johnson & Johnson outside the submitted work, and being coinventor on related vaccine patents. Dr Barouch reported receiving grants from Janssen during the conduct of the study and grants from the NIH, Henry M. Jackson Foundation/Walter Reed Army Institute of Research, the Bill and Melinda Gates Foundation, Defense Advanced Research Projects Agency, Gilead, Intima, Alkermes, CureVac, South Africa Medical Research Council, amfAR, Ragon Institute, MassCPR, Sanofi, Legend, and Zentalis and personal fees from SQZ Biotech outside the submitted work; in addition, Dr Barouch had a patent for COVID-19 vaccines pending (no premarket royalties or payments of any kind from Janssen). No other disclosures were reported.
Funding/Support: This study was funded by Janssen Vaccines & Prevention BV, the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, MassCPR, the NIH (CA260476), and BARDA (HHS0100201700018C).
Role of the Funder/Sponsor: The sponsors were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation and review of the manuscript. The sponsors were not involved in the decision to submit the manuscript for publication and did not have the right to veto publication or to control the decision regarding to which journal the paper was submitted.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank the participants and staff at the Center for Virology and Vaccine Research Clinical Trials Unit, the Harvard Catalyst Clinical Research Center, and Janssen Vaccines & Prevention.