Dahl, Angela M.
Brown, Clare E.
Brown, Elizabeth R.
O’Brien, Meagan P.
Barnabas, Ruanne V.
Funding for this research was provided by:
National Institute of Allergy and Infectious Diseases (UM1AI148684, UM1AI068619, UM1AI148684, UM1AI068619)
Regeneron Pharmaceuticals
Article History
Received: 4 August 2023
Accepted: 17 March 2024
First Online: 2 April 2024
Declarations
:
: REGN 2069/CoVPN-3502 was reviewed and approved by the central or local institutional review board (IRB) or ethics committee at each study center. The Index Individual study was reviewed and approved by the Western IRB–Copernicus Group (WCG) IRB (study no. 1294461) and by the Division of AIDS (DAIDS) (DAIDS-ES ID 38771). In both studies, written informed consent was obtained from all participants and/or their legal guardian(s). Both studies were conducted in accordance with the principles of the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice, and all applicable regulatory standards.
: Not applicable.
: E.R.B. reports participation on a data safety monitoring board for Merck and payment for expert testimony from WilmerHale. M.P.O.B. is employed by Regeneron Pharmaceuticals and reports ownership of Regeneron stock/stock options and two patents through Regeneron, one issued and one pending. R.V.B. reports support for conference abstract and manuscript writing from Regeneron Pharmaceuticals. A.M.D. and C.E.B. have no competing interests to report.