Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers. (28th August 2020)

• Record Type: Journal Article
• Authors: Levine, Myron M; Abdullah, Salim; Arabi, Yaseen M; Darko, Delese Mimi; Durbin, Anna P; Estrada, Vicente; Jamrozik, Euzebiusz; Kremsner, Peter G; Lagos, Rosanna; Pitisuttithum, Punnee; Plotkin, Stanley A; Sauerwein, Robert; Shi, Sheng-Li; Sommerfelt, Halvor; Subbarao, Kanta; Treanor, John J; Vrati, Sudhanshu; King, Deborah; Balasingam, Shobana; Weller, Charlie; Aguilar, Anastazia Older; Cassetti, M Cristina; Krause, Philip R; Restrepo, Ana Maria Henao
• Is Part Of: Clinical infectious diseases. Volume 72:Number 11(2021)
• Page Start: 2035
• Page End: 2041
• Publication Date: 2020-08-28
• Subjects: COVID-19 -- SARS-CoV-2 -- challenge model -- experimental challenge -- adult volunteers; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciaa1290
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: WHO convened an Advisory Group (AG) to consider the feasibility, potential value, and limitations of establishing a closely-monitored challenge model of experimental severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) in healthy adult volunteers. The AG included experts in design, establishment, and performance of challenges. This report summarizes issues that render a COVID-19 model daunting to establish (the potential of SARS-CoV-2 to cause severe/fatal illness, its high transmissibility, and lack of a "rescue treatment" to prevent progression from mild/moderate to severe clinical illness) and it proffers prudent strategies for stepwise model development, challenge virus selection, guidelines for manufacturing challenge doses, and ways to contain SARS-CoV-2 and prevent transmission to household/community contacts. A COVID-19 model could demonstrate protection against virus shedding and/or illness induced by prior SARS-CoV-2 challenge or vaccination. A limitation of the model is that vaccine efficacy in experimentally challenged healthy young adults cannot per se be extrapolated to predict efficacy in elderly/high-risk adults. Abstract : A WHO Advisory Group considered the feasibility, potential value, and limitations of establishing a closely-monitored challenge model of SARS-CoV-2 infection and COVID-19 in volunteers. Potential for severe illness, high virus transmissibility and lack of a "rescue treatment" pose daunting obstacles.