Publication: Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers
Issued Date
2021-06-01
Resource Type
ISSN
15376591
10584838
10584838
Other identifier(s)
2-s2.0-85094964919
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical Infectious Diseases. Vol.72, No.11 (2021), 2035-2041
Suggested Citation
Myron M. Levine, Salim Abdullah, Yaseen M. Arabi, Delese Mimi Darko, Anna P. Durbin, Vicente Estrada, Euzebiusz Jamrozik, Peter G. Kremsner, Rosanna Lagos, Punnee Pitisuttithum, Stanley A. Plotkin, Robert Sauerwein, Sheng Li Shi, Halvor Sommerfelt, Kanta Subbarao, John J. Treanor, Sudhanshu Vrati, Deborah King, Shobana Balasingam, Charlie Weller, Anastazia Older Aguilar, M. Cristina Cassetti, Philip R. Krause, Ana Maria Henao Restrepo Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers. Clinical Infectious Diseases. Vol.72, No.11 (2021), 2035-2041. doi:10.1093/cid/ciaa1290 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/78189
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers
Author(s)
Myron M. Levine
Salim Abdullah
Yaseen M. Arabi
Delese Mimi Darko
Anna P. Durbin
Vicente Estrada
Euzebiusz Jamrozik
Peter G. Kremsner
Rosanna Lagos
Punnee Pitisuttithum
Stanley A. Plotkin
Robert Sauerwein
Sheng Li Shi
Halvor Sommerfelt
Kanta Subbarao
John J. Treanor
Sudhanshu Vrati
Deborah King
Shobana Balasingam
Charlie Weller
Anastazia Older Aguilar
M. Cristina Cassetti
Philip R. Krause
Ana Maria Henao Restrepo
Salim Abdullah
Yaseen M. Arabi
Delese Mimi Darko
Anna P. Durbin
Vicente Estrada
Euzebiusz Jamrozik
Peter G. Kremsner
Rosanna Lagos
Punnee Pitisuttithum
Stanley A. Plotkin
Robert Sauerwein
Sheng Li Shi
Halvor Sommerfelt
Kanta Subbarao
John J. Treanor
Sudhanshu Vrati
Deborah King
Shobana Balasingam
Charlie Weller
Anastazia Older Aguilar
M. Cristina Cassetti
Philip R. Krause
Ana Maria Henao Restrepo
Other Contributor(s)
Faculty of Tropical Medicine, Mahidol University
Regional Centre for Biotechnology
Centro para Vacunas en Desarrollo Chile
King Saud bin Abdulaziz University for Health Sciences
Ifakara Health Institute
Universitetet i Bergen
Wuhan Institute of Virology Chinese Academy of Sciences
Universidad Complutense de Madrid
Organisation Mondiale de la Santé
University of Melbourne
University of Rochester Medical Center
Universitätsklinikum und Medizinische Fakultät Tübingen
Bill and Melinda Gates Foundation
Wellcome Trust
Monash University
National Institute of Allergy and Infectious Diseases (NIAID)
Radboud Universiteit
University of Maryland School of Medicine
Food and Drug Administration
University of Pennsylvania
Johns Hopkins Bloomberg School of Public Health
WHO RandD Blueprint COVID-19 Vaccines Working Group
Centre de Recherches Médicales de Lambaréné
Regional Centre for Biotechnology
Centro para Vacunas en Desarrollo Chile
King Saud bin Abdulaziz University for Health Sciences
Ifakara Health Institute
Universitetet i Bergen
Wuhan Institute of Virology Chinese Academy of Sciences
Universidad Complutense de Madrid
Organisation Mondiale de la Santé
University of Melbourne
University of Rochester Medical Center
Universitätsklinikum und Medizinische Fakultät Tübingen
Bill and Melinda Gates Foundation
Wellcome Trust
Monash University
National Institute of Allergy and Infectious Diseases (NIAID)
Radboud Universiteit
University of Maryland School of Medicine
Food and Drug Administration
University of Pennsylvania
Johns Hopkins Bloomberg School of Public Health
WHO RandD Blueprint COVID-19 Vaccines Working Group
Centre de Recherches Médicales de Lambaréné
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.