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dc.contributor.authorOsowicki, Joshua
dc.contributor.authorAzzopardi, Kristy
dc.contributor.authorBaker, Ciara
dc.contributor.authorWaddington, Claire S
dc.contributor.authorPandey, Manisha
dc.contributor.authorSchuster, Tibor
dc.contributor.authorGrobler, Anneke
dc.contributor.authorCheng, Allen C
dc.contributor.authorPollard, Andrew J
dc.contributor.authorMcCarthy, James S
dc.contributor.authorGood, Michael F
dc.contributor.authorWalker, Mark J
dc.contributor.authorDale, James B
dc.contributor.authorBatzloff, Michael R
dc.contributor.authorCarapetis, Jonathan R
dc.contributor.authorSmeesters, Pierre R
dc.contributor.authorSteer, Andrew C
dc.date.accessioned2019-07-15T23:11:16Z
dc.date.available2019-07-15T23:11:16Z
dc.date.issued2019
dc.identifier.issn0264-410X
dc.identifier.doi10.1016/j.vaccine.2019.03.059
dc.identifier.urihttp://hdl.handle.net/10072/386433
dc.description.abstractGroup 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).
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofpagefrom3485
dc.relation.ispartofpageto3494
dc.relation.ispartofissue26
dc.relation.ispartofjournalVaccine
dc.relation.ispartofvolume37
dc.subject.fieldofresearchBiological Sciences
dc.subject.fieldofresearchAgricultural and Veterinary Sciences
dc.subject.fieldofresearchMedical and Health Sciences
dc.subject.fieldofresearchcode06
dc.subject.fieldofresearchcode07
dc.subject.fieldofresearchcode11
dc.titleControlled human infection for vaccination against Streptococcus pyogenes (CHIVAS): Establishing a group A Streptococcus pharyngitis human infection study
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.hasfulltextNo Full Text
gro.griffith.authorGood, Michael F.
gro.griffith.authorPandey, Manisha
gro.griffith.authorBatzloff, Michael R.


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