1:00-2:00 pm EDT

Chairperson: Rob Burgess, PhD, Chief Business Officer, Sino Biological

1:00 Application of SARS-CoV-2 Serological Assays for Monitoring the Epidemic and Qualification of Donors and Plasma for Use as COVID-19 Convalescent Plasma (CCP)

Michael P. Busch, MD, PhD, Director, Vitalant Research Institute; Senior Vice President for Research and Scientific Programs, Vitalant; Professor of Laboratory Medicine, University of California, San Francisco

Vitalant Research Institute (VRI) has developed and is driving two large studies related to SARS-CoV-2/COVID-19. One study, funded by the NHLBI and NIAID, is titled RESPONSE (REDS Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic).

The RESPONSE study will evaluate the rates of SARS-CoV-2 RNA in 300,000 donations in minipools and SARS-CoV-2 Abs 36,000 donations in 6 US blood collection regions. It will also track rates of COVID-19 post-donation information (PDI) reports with donation plasma tested for RNA, recipients tested to investigate potential transfusion transmission, as well as 150 PDI donors with infection followed for 12 months with collection of longitudinal serum and PMBC samples for characterization of immune responses over time and to establish a sharable repository for pathogenesis and vaccine research.

In addition, we are leading a large CDC-funded national serosurvey to apply SARS-CoV-2 Ab assays to test 340,000 blood donor samples collected in monthly serial cross-sectional waves in 25 regions within the US. This study will also follow 150 convalescent plasma donors for 18 months with characterization of SARS-CoV-2 antibody dynamics over time using multiple high-throughput platforms, a novel pseudotyped SARS-CoV-2 reporter viral particle neutralizing assay to perform high-throughput titration to qualify COVID-19 Convalescent Plasma (CCP), and a respiratory viral protein array assay developed by Dr. Philip Felgner’s team at UC Irvine in partnership with Sino Biological.

1:20 Optimized Development of Pathogen Inactivated COVID-19 Convalescent Plasma

Laurence M. Corash, MD, Co-Founder & CSO, Cerus

COVID-19 is a highly contagious and morbid infectious disease resulting in severe pulmonary injury caused by a novel emerging respiratory pathogen, SARS-CoV-2. Currently there are limited therapeutic options and limited resources for support of patients with COVID-19 acute respiratory failure – the major cause of death.

Transfusion of plasma containing neutralizing antibodies (Ab) to SARS-CoV-2 from asymptomatic or convalescent COVID-19 donors is a potential near-term therapeutic option to prevent or mitigate tissue injury provided that these antibodies effectively neutralize SARS-CoV-2 infection and do not cause antibody dependent COVID-19 enhancement.

Prior experience with immune plasma therapy has shown reduced mortality of Argentine Hemorrhagic Fever and reduced time to hospital discharge for SARS. Therapeutic convalescent plasma (CP) with amotosalen-UVA pathogen inactivation (PI) treatment has been prepared from convalescent Ebola virus patients with retention of Ab neutralization efficacy; and safely transfused to acutely infected patients. PI treatment of CP is an important measure to mitigate risk of blood-borne pathogen transmission, especially since pooled donor plasma collections to enhance Ab diversity may be optimal for efficacy and these donors do not meet the criteria for qualified healthy blood donors.

This approach is enabled by FDA licensure of amotosalen-UVA plasma including SARS CoV inactivation, and more than 10 years of clinical experience demonstrating safety and efficacy. The therapeutic efficacy of pathogen inactivated COVID-19 convalescent plasma will be optimized by characterization of antibody titers and epitope profiles.

1:40 Analysis of SARS-CoV-2 Antibodies in COVID-19 Convalescent Plasma Using a Coronavirus Antigen Microarray

Philip Felgner, PhD, Director, Protein Microarray Laboratory, Infectious Diseases, School of Medicine, University of California, Irvine

The current practice for diagnosis of COVID-19, based on SARS-CoV-2 PCR testing of pharyngeal or respiratory specimens in a symptomatic patient at high epidemiologic risk, likely underestimates the true prevalence of infection. Serologic methods can more accurately estimate the disease burden by detecting infections missed by the limited testing performed to date.

Here, we describe the validation of a coronavirus antigen microarray containing immunologically significant antigens from SARS-CoV-2, in addition to SARS-CoV, MERS-CoV, common human coronavirus strains, and other common respiratory viruses. A comparison of antibody profiles detected on the array from control sera collected prior to the SARS-CoV-2 pandemic versus convalescent blood specimens from virologically confirmed COVID-19 cases demonstrates complete discrimination of these two groups.

This array can be used as a diagnostic tool, as an epidemiologic tool to more accurately estimate the disease burden of COVID-19, and as a research tool to correlate antibody responses with clinical outcomes.