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Experimental infection of human volunteers.

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Roestenberg, Meta, Hoogerwerf, Marie-Astrid, Ferreira, Daniela ORCID: https://orcid.org/0000-0001-7730-9477, Mordmüller, Benjamin and Yazdanbakhsh, Maria (2018) 'Experimental infection of human volunteers.'. Lancet Infectious Diseases, Vol 18, Issue 10, e312-e322.

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Abstract

Controlled human infection (CHI) trials, in which healthy volunteers are experimentally infected, can accelerate the development of novel drugs and vaccines for infectious diseases of global importance. The use of CHI models is expanding from around 60 studies in the 1970s to more than 120 publications in this decade, primarily for influenza, rhinovirus, and malaria. CHI trials have provided landmark data for several registered drugs and vaccines, and have generated unprecedented scientific insights. Because of their invasive nature, CHI studies demand critical ethical review according to established frameworks. CHI-associated serious adverse events are rarely reported. Novel CHI models need standardised safety data from comparable CHI models to facilitate evidence-based risk assessments, as well as funds to produce challenge inoculum according to regulatory requirements. Advances such as the principle of controlled colonisation, the expansion of models to endemic areas, and the use of genetically attenuated strains will further broaden the scope of CHI trials.

Item Type: Article
Subjects: QW Microbiology and Immunology > Viruses > QW 160 Viruses (General). Virology
W General Medicine. Health Professions > W 20.5 Biomedical research
WA Public Health > WA 4 Works on general hygiene
WC Communicable Diseases > WC 20 Research (General)
WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 515 Human influenza
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1016/S1473-3099(18)30177-4
Depositing User: Stacy Murtagh
Date Deposited: 13 Jun 2018 10:46
Last Modified: 08 Dec 2018 02:02
URI: https://archive.lstmed.ac.uk/id/eprint/8770

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