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dc.creatorRustomjee, R.
dc.creatorMcleod, R.
dc.creatorHanekom, W.
dc.creatorSteel, G.
dc.creatorMahomed, H.
dc.creatorHawkridge, Anthony.
dc.creatorWelte, A.
dc.creatorSinanovic, E.
dc.creatorLoots, G.
dc.creatorGrobler, Anna Christina.
dc.creatorMvusi, L.
dc.creatorGray, Glenda E.
dc.creatorHesseling, A.
dc.creatorGinsberg, A.
dc.creatorLienhardt, C.
dc.creatorShea, J.
dc.creatorTong, X.
dc.creatorLockhart, S.
dc.creatorChurchyard, Gavin J.
dc.date.accessioned2013-07-01T13:16:21Z
dc.date.available2013-07-01T13:16:21Z
dc.date.created2012
dc.date.issued2012-09
dc.identifier.citationRustomjee, R. et al. 2012. Key issues in the clinical development and implementation of TB vaccines in South Africa. Tuberculosis 92 (5) pp. 359-364.en
dc.identifier.issn1472-9792
dc.identifier.urihttp://dx.doi.org/10.1016/j.tube.2012.05.001en
dc.identifier.urihttp://hdl.handle.net/10413/9239
dc.description.abstractSignificant progress has been made in advancing the development pipeline for a new and more effective TB vaccine with some candidate vaccines now in late stage clinical evaluation. However, progress has been hampered by an incomplete understanding of the components of a protective immune response and limited animal models, rendering the field unable to reliably predict vaccine efficacy earlier in preclinical development, including by evaluation in animal models, and limiting the predictive utility of comparing immunogenic effects across vaccine candidates in phase I/II studies. Consequently, new candidate vaccines have to be evaluated for efficacy in large-scale phase II/III trials using clinical endpoints. Apart from the technical challenges of characterising TB incidence in target populations at high risk of acquiring TB disease and standardising case definitions in order to improve both the sensitivity and more importantly the specificity of trial endpoints, there is an urgency in expanding and supporting the considerable trial infrastructure that will be required to evaluate and ultimately license a new TB vaccine. In the longer term, implementation strategies are dependent on what policy makers most value. Economic analyses will be essential to guide policy and implementation. This paper outlines the gaps and challenges and identifies solutions for effectively developing and efficiently introducing a new TB vaccine.en
dc.language.isoenen
dc.publisherElsevier.en
dc.subjectTuberculosis--Vaccination--South Africa.en
dc.subjectTuberculosis--Epidemiology--South Africa.en
dc.subject.otherMVA85Aen
dc.titleKey issues in the clinical development and implementation of TB vaccines in South Africa.en
dc.typePeer reviewed journal articleen


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