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  • Controlled human infection for vaccination against Streptococcus pyogenes (CHIVAS): Establishing a group A Streptococcus pharyngitis human infection study

    Author(s)
    Osowicki, Joshua
    Azzopardi, Kristy
    Baker, Ciara
    Waddington, Claire S
    Pandey, Manisha
    Schuster, Tibor
    Grobler, Anneke
    Cheng, Allen C
    Pollard, Andrew J
    McCarthy, James S
    Good, Michael F
    Walker, Mark J
    Dale, James B
    Batzloff, Michael R
    Carapetis, Jonathan R
    Smeesters, Pierre R
    Steer, Andrew C
    Griffith University Author(s)
    Good, Michael F.
    Pandey, Manisha
    Batzloff, Michael R.
    Year published
    2019
    Metadata
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    Abstract
    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. ...
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    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).
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    Journal Title
    Vaccine
    Volume
    37
    Issue
    26
    DOI
    https://doi.org/10.1016/j.vaccine.2019.03.059
    Subject
    Biological Sciences
    Agricultural and Veterinary Sciences
    Medical and Health Sciences
    Publication URI
    http://hdl.handle.net/10072/386433
    Collection
    • Journal articles

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