COVID-19 Clinical Support and Research

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

In March 2020 the VIP began working in collaboration with VRC laboratories on the trial readouts for the Phase 1 DMID 20-0003 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 in collaboration with Nicole Doria Rose (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. These manuscripts have now been published. The end point testing laboratory has undergone audits from industry and was successfully accredited for GCLP testing in 2021 and maintains its accreditation. 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. The laboratory continues to develop and expand upon the capabilities for Phase I through Phase III trial support and clinical correlate of protection testing. For example, we have improved QMS, expanded equipment capacity, instrumentation and personnel, sample traceability with data transfer plan, technology transfer and maintenance of FDA Drug Master Files. The VIP tested over 50,000 samples that were uploaded for correlates of protection and immunogenicity studies. In the current year, the VIP has also aided in endpoint testing for DMID 21-0002, DMID 20-0003, DMID 21-0012, WRAIR EID030 and DMID 22-0004 trials as well as additional investigation into vaccine efficacy trials in immunocompromised individuals (CPAT and ACV01). The continued emergence of new variants of concern initiated development of 10-plex assay readouts to better characterize individual's serological landscape. Hence, the VIP has continued to aid in profiling SARS-CoV-2 serology and has generated over 100,000 test results for the 2022 fiscal year. In addition, the VIP investigated basic B and T cell immunobiology to elucidated the mechanisms that drive SARS-CoV-2 transmission, immune escape, and to inform the development of new generations of variant-targeting vaccines. VIP will continue to develop sophisticated analyses that supports in-depth investigation of SARS-CoV-2 through clinical assays for use in IND submissions and product licensure purposes as well as profiling and screening of B-cell responses to evaluate vaccine regimens and identify monoclonal therapeutics. 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.