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dc.contributor.authorHaselbeck, A.H.
dc.contributor.authorTadesse, B.T.
dc.contributor.authorPark, J.
dc.contributor.authorGibani, M.M.
dc.contributor.authorEspinoza, L.M.C.
dc.contributor.authorAbreu, A.
dc.contributor.authorVan, Rensburg, C.
dc.contributor.authorAguna, I.
dc.contributor.authorTonks, S.
dc.contributor.authorOwusu-Ansah, M.en_US
dc.contributor.authorTwuamsi-Ankrah, S.en_US
dc.contributor.authorOwusu, M.en_US
dc.contributor.authorAguna, I.en_US
dc.contributor.authorPicot, V.en_US
dc.contributor.authorJeon, H.en_US
dc.contributor.authorHigginson, E.en_US
dc.contributor.authorPark, S.en_US
dc.contributor.authorMojares, Z.R.en_US
dc.contributor.authorIm, J.en_US
dc.contributor.authorCarey, M.E.en_US
dc.contributor.authorKhanam, F.en_US
dc.contributor.authorTonks, S.en_US
dc.contributor.authorDougan, G.en_US
dc.contributor.authorKim, D.en_US
dc.contributor.authorSugimoto, J.en_US
dc.contributor.authorMogasale, V.en_US
dc.contributor.authorNeuzil, K.en_US
dc.contributor.authorQadri, F.en_US
dc.contributor.authorAdu-Sarkodie, Y.en_US
dc.contributor.authorOwusu-Dabo, E.en_US
dc.contributor.authorClemens, J.en_US
dc.contributor.authorMarks, F.en_US
dc.date.accessioned2021-04-12T13:11:09Z
dc.date.available2021-04-12T13:11:09Z
dc.date.issued2021-03-19
dc.identifier.urihttp://hdl.handle.net/10713/15154
dc.description.abstractTyphoid fever remains a significant health problem in sub‐Saharan Africa, with incidence rates of >100 cases per 100,000 person‐years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), some uncertainties remain around future demand. Real‐life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid‐related mortality and morbidity, from an African setting may help encourage the introduction of TCVs in high‐burden settings. Here, we describe a cluster‐randomized trial to investigate population‐level protection of TYPBAR‐TCV®, a Vi‐polysaccharide conjugated to a tetanus‐toxoid protein carrier (Vi‐TT) against blood‐culture‐confirmed typhoid fever, and the synthesis of health economic evidence to inform policy decisions. A total of 80 geographically distinct clusters are delineated within the Agogo district of the Asante Akim region in Ghana. Clusters are randomized to the intervention arm receiving Vi‐TT or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the total protection of Vi‐TT against blood‐culture‐confirmed typhoid fever. Total, direct, and indirect protection are measured as secondary outcomes. Blood‐culture‐based enhanced surveillance enables the estimation of incidence rates in the intervention and control clusters. Evaluation of the real‐world impact of TCVs and evidence synthesis improve the uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings. This trial is registered at the Pan African Clinical Trial Registry, accessible at Pan African Clinical Trials Registry (ID: PACTR202011804563392). © 2021 by the authors.en_US
dc.description.sponsorshipFunding: This research funded as part of the EDCTP2 programme supported by the European Union (RIA2017S-2027) and as a grant from the Bill & Melinda Gates Foundation (OPP1205877). Disclaimer: This manuscript reflects only the authors' view and does not necessarily represent the official position of the Bill & Melinda Gates Foundation and the EDCTP Association.en_US
dc.description.urihttps://doi.org/10.3390/vaccines9030281en_US
dc.language.isoen_USen_US
dc.publisherMDPI AGen_US
dc.relation.ispartofVaccines
dc.subjectCluster randomized trialen_US
dc.subjectGhanaen_US
dc.subjectTyphoid conjugate vaccineen_US
dc.subjectTyphoid feveren_US
dc.titleEvaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) Using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristicsen_US
dc.typeArticleen_US
dc.identifier.doi10.3390/vaccines9030281


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