COVID_19_VE_Trial_Marker_SAP_18_Apr_2022.pdf (2.09 MB)

USG COVID-19 Response Team / CoVPN Vaccine Efficacy Trial Immune Correlates Statistical Analysis Plan

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posted on 2022-04-18, 18:39 authored by USG COVID-19 Response Team / Coronavirus Prevention Network (CoVPN) Biostatistics Team, Peter B. Gilbert, Youyi Fong, David Benkeser, Jessica Andriesen, Bhavesh BorateBhavesh Borate, Marco Carone, Lindsay N. CarppLindsay N. Carpp, Ivan Diaz, Michael P. Fay, Andrew Fiore-GartlandAndrew Fiore-Gartland, Nima S. Hejazi, Ying Huang, Yunda Huang, Ollivier Hyrien, Holly E. Janes, Michal Juraska, Kendrick Li, Alex Luedtke, Martha Nason, April K. Randhawa, Lars van der Laan, Brian Williamson, Wenbo Zhang, Dean Follmann
This Statistical Analysis Plan (SAP) describes the statistical analysis of antibody markers measured at a key time point post last vaccination as correlates of risk and as various types of correlates of protection against primary and secondary endpoints in COVID-19 Prevention Network (CoVPN) COVID-19 vaccine efficacy (VE) trials.


National Institute of Allergy and Infectious Diseases (NIAID) UM1AI068635

National Institute of Allergy and Infectious Diseases (NIAID) R37AI054165