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Principal Investigator: Adrian McDermott
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2020
Award: $4,108,341
Funding agency: National Institute of Allergy and Infectious Diseases
In March 2020 the VIP began working in collaboration with VRC laboratories on the trial readouts for the Phase 1 DIMID 20-003 trial. The VIPs original focus was on the standard ELISA automated assay developing the readout for the SARS COV-2 S2P, RBD and N proteins. Pseudovirus neutralization was included with Dr. Graham (VRC) and David Montefiori (Duke). Increased concentration on ELISA development led to single-plex and 4-plex assay development, for higher throughput inclusive of qualification to phase 3 clinical trial validation with standardized documentation and implementation of protocols. VIP Phase I testing support led to the development of a comprehensive workflow to follow full sample chain of custody from reception to results reporting/upload. Audit for Phase I and Phase III support determined the improved QMS, Equipment capacity, expanded instrumentation and personnel, sample traceability with data transfer plan, Technology transfer and FDA Drug master Files.
In addition, the VIP will investigate basic B and T cell immunobiology to elucidate the mechanisms that drive the SARS CoV-2 transmission and to inform the improved development of second generation vaccines. VIP will continue to develop sophisticated analyses that supports in-depth investigation of SARS CoV 2 through sero-surveillance multi investigator collaborative studies, clinical vaccine trials, including highly qualified clinical assays for use in IND submissions and product licensure purposes. This template of advanced serological and cellular analyses for emerging pathogens will be extended for Vaccine Preparedness efforts at the VRC and NIAID in general.
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