About: The human viral challenge model: accelerating the evaluation of respiratory antivirals, vaccines and novel diagnostics

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About: The human viral challenge model: accelerating the evaluation of respiratory antivirals, vaccines and novel diagnostics Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	The human viral challenge model: accelerating the evaluation of respiratory antivirals, vaccines and novel diagnostics
Creator	Catchpole, Andrew Lambkin-Williams, Rob Mann, Alex Noulin, Nicolas Gilbert, Anthony
Source	Medline; PMC
abstract	The Human Viral Challenge (HVC) model has, for many decades, helped in the understanding of respiratory viruses and their role in disease pathogenesis. In a controlled setting using small numbers of volunteers removed from community exposure to other infections, this experimental model enables proof of concept work to be undertaken on novel therapeutics, including vaccines, immunomodulators and antivirals, as well as new diagnostics. Crucially, unlike conventional phase 1 studies, challenge studies include evaluable efficacy endpoints that then guide decisions on how to optimise subsequent field studies, as recommended by the FDA and thus licensing studies that follow. Such a strategy optimises the benefit of the studies and identifies possible threats early on, minimising the risk to subsequent volunteers but also maximising the benefit of scarce resources available to the research group investing in the research. Inspired by the principles of the 3Rs (Replacement, Reduction and Refinement) now commonly applied in the preclinical phase, HVC studies allow refinement and reduction of the subsequent development phase, accelerating progress towards further statistically powered phase 2b studies. The breadth of data generated from challenge studies allows for exploration of a wide range of variables and endpoints that can then be taken through to pivotal phase 3 studies. We describe the disease burden for acute respiratory viral infections for which current conventional development strategies have failed to produce therapeutics that meet clinical need. The Authors describe the HVC model’s utility in increasing scientific understanding and in progressing promising therapeutics through development. The contribution of the model to the elucidation of the virus-host interaction, both regarding viral pathogenicity and the body’s immunological response is discussed, along with its utility to assist in the development of novel diagnostics. Future applications of the model are also explored. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12931-018-0784-1) contains supplementary material, which is available to authorized users.
has issue date	2018-06-22(xsd:dateTime)
bibo:doi	10.1186/s12931-018-0784-1
bibo:pmid	29929556
has license	cc-by
sha1sum (hex)	f13c88733ea45be9e923a282dfd42f8c277c187c
schema:url	https://doi.org/10.1186/s12931-018-0784-1
resource representing a document's title	The human viral challenge model: accelerating the evaluation of respiratory antivirals, vaccines and novel diagnostics
has PubMed Central identifier	PMC6013893
has PubMed identifier	29929556
schema:publication	Respir Res
resource representing a document's body	covid:f13c88733ea45be9e923a282dfd42f8c277c187c#body_text
is schema:about of	named entity 'HVC' named entity 'therapeutics' named entity 'Authors' named entity 'reduction' named entity 'refinement' named entity 'Refinement' named entity 'enables' named entity 'endpoints' named entity 'volunteers' named entity 'failed' named entity 'EVALUATION' named entity 'ANTIVIRALS' named entity 'ACUTE' named entity 'LICENSING' named entity 'INFECTIONS' named entity 'AVAILABLE' named entity 'PROGRESSING' named entity 'HUMAN' named entity 'PHASE 1' named entity 'THREATS' named entity 'HUMAN' named entity 'GUIDE' named entity 'UTILITY' named entity 'ANTIVIRALS' named entity 'NUMBERS' named entity 'HVC' named entity 'DECISIONS' named entity 'EXPOSURE TO' named entity 'DISEASE' named entity 'USING' named entity 'STRATEGY' named entity 'POWERED' named entity 'CHALLENGE' named entity 'NEED' named entity 'PHASE 3' named entity 'GENERATED' named entity 'INSPIRED' named entity 'INCLUDE' named entity 'VARIABLES' named entity 'CONVENTIONAL' named entity 'REFINEMENT' named entity 'ROLE' named entity 'BUT' named entity 'RESPIRATORY' named entity 'NOVEL THERAPEUTICS' named entity 'CURRENT' named entity 'EFFICACY' named entity 'PHASE 2B' named entity 'FDA' named entity 'CHALLENGE' named entity 'DIAGNOSTICS' named entity 'VACCINES' named entity 'MODEL' named entity 'TO PRODUCE' named entity 'STUDIES' named entity 'BREADTH' named entity 'RANGE' named entity 'IMMUNOMODULATORS' named entity 'CONTROLLED' named entity 'BENEFIT' named entity 'ALLOW' named entity 'RESOURCES' named entity 'EVALUABLE' named entity 'SETTING' named entity 'STRATEGIES' named entity 'RESEARCH' named entity 'ENABLES' named entity 'ENDPOINTS' named entity 'FIELD' named entity 'SCIENTIFIC' named entity 'APPLIED' named entity 'VIRAL INFECTIONS' named entity 'VACCINES' named entity 'WORK' named entity 'HAVE' named entity 'EXPLORATION' named entity 'BURDEN'

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