COVID-19 Clinical Support and Research

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

In March 2020 the VIP began working in collaboration with VRC laboratories on the trial readouts for the Phase 1 DIMID 20-003 trial. Later that year the VIP was working within the Operation Warp Speed (OWS) (now called Countermeasures Accelerations Group) testing USG identified CoVID-19 vaccines. The VIP's 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 MSD ECLIA 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. These assays were deployed by the VIP for OWS correlates of protection analyses. 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. The VIP tested approximately 30,000 samples that were uploaded for correlates of protection and immunogenicity studies. In addition, the VIP investigated basic B and T cell immunobiology to elucidated the mechanisms that drive the SARS CoV-2 transmission and to inform the improved development of second generation variant vaccines and third dose. 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.