To address the urgent needs to develop a vaccine that will protect the population against COVD-19, the Vaccine Treatment and Evaluation Unit (VTEU) team at the Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore (UMB) proposes a 3-pronged approach that involves contributions to leadership, COVID-19 clinical trial implementation, and surge capacity. First, Dr. Kotloff, UMB's VTEU Principal Investigator (PI), will serve as the protocol co-chair on the Phase 3 trial (Protocol 2019nCoV-301) sponsored by Novavax to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS vaccine and Matrix-M1 adjuvant to prevent COVID-19 in adult participants ? 18 years of age. She will oversee protocol development in conjunction with a team of experts from Novavax, the COVID-19 Prevention Network (CoVPN), Biomedical Advanced Research and Development Authority (BARDA), and Operation Warp Speed (OWS). She will assist with development of policies and procedures related to site selection in order to enroll a demographically diverse population of individuals at increased risk of acquiring SARS CoV-2 and progressing to severe disease. She will contribute to approaches for study preparedness, analysis, and implementation to facilitate the expeditious execution of these activities. Second, the UMB VTEU team will participate as a clinical site in this randomized, observer-blinded, placebo- controlled Phase 3 trial of the Novavax vaccine. To accomplish this aim we will utilize our personnel, resources, and organizational structures that have been adapted to expeditiously enroll and retain a demographically diverse population of individuals at high risk of acquisition of SARS-CoV-2 infection and disease. We will enroll up to 500 subjects, administer study product on days 0 and 21, and perform all study procedures within the expected time frame and in accordance with the protocol. Third, to fulfill our mission to provide surge capacity of suitable populations of subjects across a spectrum of ages and disease vulnerabilities to address public health emergencies, the UMB VTEU team will execute a subcontract to engage our collaborators at State University of New York ? Upstate in the performance the COVID-19 Phase 3 vaccine efficacy trial sponsored by Sanofi-GSK. The SUNY-Upstate team has substantial experience in conducting complex clinical trials of vaccines and infectious agents with access to a large, demographically diverse population. We will oversee all aspects of study conduct at the SUNY-Upstate site, including volunteer recruitment, enrollment, assessment, and performance of study procedures according to GCP and the clinical protocol, as well as providing the required administrative and financial oversight.
To address the urgent needs to develop a vaccine that will protect the population against COVD-19, the Vaccine Treatment and Evaluation Unit (VTEU) team at the Center for Vaccine Development and Global Health (CVD), University of Maryland, Baltimore (UMB), proposes a 3-pronged approach: 1) To provide leadership - Dr. Kotloff, UMB's VTEU Principal Investigator (PI), will serve as the protocol co-chair on the Phase 3 vaccine efficacy trial sponsored by Novavax, Inc. overseeing development of the protocol in conjunction with a team of experts from Novavax, the COVID-19 Prevention Network, BARDA, and Operation Warp Speed; 2) To contribute to clinical vaccine trial implementation - the UMB VTEU team will enroll up to 500 participants in the Novavax Phase 3 COVID-19 Phase 3 vaccine trial; and 3) To provide surge capacity - the UMB VTEU team will oversee all aspects of the implementation of the COVID-19 Phase 3 vaccine sponsored by Sanofi-GSK at State University of New York ? Upstate.