COVID_19_VE_Trial_Marker_SAP_15_Feb_2021.pdf (1.68 MB)

OWS CoVPN COVID-19 Vaccine Efficacy Trial Immune Correlates Statistical Analysis Plan

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posted on 15.02.2021, 14:43 by CoVPN Biostatistics Team, Peter B. Gilbert, Youyi Fong, David Benkeser, Jessica Andriesen, Bhavesh Borate, Marco Carone, Lindsay N. Carpp, Ivan Diaz, Michael P. Fay, 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