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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Controlled human infection for vaccination against Streptococcus pyogenes (CHIVAS): Establishing a group A Streptococcus pharyngitis human infection study
Vaccine, Volume 37, No. 26, Year 2019
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Description
Group A Streptococcus (GAS) is a highly-adapted and human-restricted pathogen responsible for a high global burden of disease across a diverse clinical spectrum. Vaccine development has been impeded by scientific, regulatory, and commercial obstacles. Human infection studies (HIS) are increasingly contributing to drug, diagnostics, and vaccine development, reducing uncertainty at early stages, especially for pathogens with animal models that incompletely reproduce key elements of human disease. We review the small number of historical GAS HIS and present the study protocol for a dose-ranging inpatient study in healthy adults. The primary objective of the study is to establish a new GAS pharyngitis HIS with an attack rate of at least 60% as a safe and reliable platform for vaccine evaluation and pathogenesis research. According to an adaptive dose-ranging study design, emm75 GAS doses manufactured in keeping with principles of Good Manufacturing Practice will be directly applied by swab to the pharynx of carefully screened healthy adult volunteers at low risk of severe complicated GAS disease. Participants will remain as closely monitored inpatients for up to six days, observed for development of the primary outcome of acute symptomatic pharyngitis, as defined by clinical and microbiological criteria. All participants will be treated with antibiotics and followed as outpatients for six months. An intensive sampling schedule will facilitate extensive studies of host and organism dynamics during experimental pharyngitis. Ethics approval has been obtained and the study has been registered at ClinicalTrials.gov (NCT03361163). © 2019 Elsevier Ltd
Authors & Co-Authors
Osowicki, Joshua
Australia, Melbourne
Murdoch Children's Research Institute
Australia, Melbourne
University of Melbourne
Australia, Melbourne
Royal Children's Hospital, Melbourne
Azzopardi, Kristy I.
Australia, Melbourne
Murdoch Children's Research Institute
Waddington, Claire S.
Australia, Perth
The University of Western Australia
United Kingdom, Cambridge
University of Cambridge
Schuster, Tibor
Australia, Melbourne
Murdoch Children's Research Institute
Canada, Montreal
Université Mcgill
Grobler, Anneke C.
Australia, Melbourne
University of Melbourne
Australia, Melbourne
Murdoch Children's Research Institute
Cheng, Allen C.
Australia, Melbourne
The Alfred
Australia, Clayton
Monash University
Pollard, Andrew J.
United Kingdom, Oxford
University of Oxford Medical Sciences Division
United Kingdom, Oxford
Nihr Oxford Biomedical Research Centre
McCarthy, James S.
Australia, Brisbane
Qimr Berghofer Medical Research Institute
Australia, Brisbane
The University of Queensland
Good, Michael F.
Australia, Brisbane
Griffith University
Walker, Mark J.
Australia, Brisbane
Australian Infectious Diseases Research Centre
Dale, J. B.
United States, Memphis
University of Tennessee Health Science Center
Batzloff, Michael R.
Australia, Brisbane
Griffith University
Carapetis, Jonathan Rhys
Australia, Perth
The University of Western Australia
Smeesters, Pierre R.
Australia, Melbourne
Murdoch Children's Research Institute
Australia, Melbourne
University of Melbourne
Belgium, Brussels
Université Libre de Bruxelles
Steer, Andrew C.
Australia, Melbourne
Murdoch Children's Research Institute
Australia, Melbourne
University of Melbourne
Australia, Melbourne
Royal Children's Hospital, Melbourne
Statistics
Citations: 22
Authors: 15
Affiliations: 16
Identifiers
Doi:
10.1016/j.vaccine.2019.03.059
ISSN:
0264410X