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dc.contributor.authorDella Cioppa, Giovanni
dc.contributor.authorJonsdottir, Ingileif
dc.contributor.authorLewis, David
dc.date.accessioned2015-07-30T11:48:36Zen
dc.date.available2015-07-30T11:48:36Zen
dc.date.issued2015-06-08en
dc.date.submitted2015en
dc.identifier.citationVaccine 2015, 33 Suppl 2:B47-51en
dc.identifier.issn1873-2518en
dc.identifier.pmid26022568en
dc.identifier.doi10.1016/j.vaccine.2015.02.031en
dc.identifier.urihttp://hdl.handle.net/2336/561232en
dc.descriptionTo access publisher's full text version of this article click on the hyperlink at the bottom of the pageen
dc.description.abstractA three-step approach to the early development of adjuvanted vaccine candidates is proposed, the goal of which is to allow ample space for exploratory and hypothesis-generating human experiments and to select dose(s) and dosing schedule(s) to bring into full development. Although the proposed approach is more extensive than the traditional early development program, the authors suggest that by addressing key questions upfront the overall time, size and cost of development will be reduced and the probability of public health advancement enhanced. The immunogenicity end-points chosen for early development should be critically selected: an established immunological parameter with a well characterized assay should be selected as primary end-point for dose and schedule finding; exploratory information-rich end-points should be limited in number and based on pre-defined hypothesis generating plans, including system biology and pathway analyses. Building a pharmacodynamic profile is an important aspect of early development: to this end, multiple early (within 24h) and late (up to one year) sampling is necessary, which can be accomplished by sampling subgroups of subjects at different time points. In most cases the final target population, even if vulnerable, should be considered for inclusion in early development. In order to obtain the multiple formulations necessary for the dose and schedule finding, "bed-side mixing" of various components of the vaccine is often necessary: this is a complex and underestimated area that deserves serious research and logistical support.
dc.description.sponsorshipNovartis Vaccines and Diagnosticsen
dc.language.isoenen
dc.publisherElsevieren
dc.relation.urlhttp://dx.doi.org/ 10.1016/j.vaccine.2015.02.031en
dc.relation.urlhttp://ac.els-cdn.com/S0264410X15002091/1-s2.0-S0264410X15002091-main.pdf?_tid=5cc621f8-36af-11e5-9f38-00000aab0f6c&acdnat=1438256430_c52a6af93c20d0061c059d894f41c80cen
dc.rightsArchived with thanks to Vaccineen
dc.subjectKrabbameinen
dc.subjectMeðferðen
dc.subject.meshChemoradiotherapy, Adjuvanten
dc.subject.meshBiological Markersen
dc.subject.meshNeoplasms/therapy*en
dc.subject.meshCancer Vaccines/therapeutic use*en
dc.titleChallenges in early clinical development of adjuvanted vaccines.en
dc.typeArticleen
dc.contributor.department[ 1 ] GlaxoSmithKline, I-53100 Siena, Italy [ 2 ] Natl Univ Hosp Reykjavik, Landspitali, IS-101 Reykjavik, Iceland [ 3 ] Univ Iceland, IS-101 Reykjavik, Iceland [ 4 ] Univ Surrey, Clin Res Ctr, Guildford CU2 7XP, Surrey, Englanden
dc.identifier.journalVaccineen
dc.rights.accessNational Consortium - Landsaðganguren
html.description.abstractA three-step approach to the early development of adjuvanted vaccine candidates is proposed, the goal of which is to allow ample space for exploratory and hypothesis-generating human experiments and to select dose(s) and dosing schedule(s) to bring into full development. Although the proposed approach is more extensive than the traditional early development program, the authors suggest that by addressing key questions upfront the overall time, size and cost of development will be reduced and the probability of public health advancement enhanced. The immunogenicity end-points chosen for early development should be critically selected: an established immunological parameter with a well characterized assay should be selected as primary end-point for dose and schedule finding; exploratory information-rich end-points should be limited in number and based on pre-defined hypothesis generating plans, including system biology and pathway analyses. Building a pharmacodynamic profile is an important aspect of early development: to this end, multiple early (within 24h) and late (up to one year) sampling is necessary, which can be accomplished by sampling subgroups of subjects at different time points. In most cases the final target population, even if vulnerable, should be considered for inclusion in early development. In order to obtain the multiple formulations necessary for the dose and schedule finding, "bed-side mixing" of various components of the vaccine is often necessary: this is a complex and underestimated area that deserves serious research and logistical support.


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