Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies

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Balasingam, Shobana (author)

Randomized controlled trials for influenza drugs and vaccines : a review of controlled human infection studies

Article/chapterEnglish2016

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Elsevier,2016
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LIBRIS-ID:oai:DiVA.org:umu-127475
https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-127475URI
https://doi.org/10.1016/j.ijid.2016.05.013DOI

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Language:English
Summary in:English

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Subject category:ref swepub-contenttype
Subject category:for swepub-publicationtype

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OBJECTIVES: Controlled human infection, the intentional infection of healthy volunteers, allows disease pathogenesis to be studied and vaccines and therapeutic interventions to be evaluated in a controlled setting. A systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform was performed. The primary objective was to document the scope of trials performed to date and the main efficacy outcome in the trials. The secondary objective was to assess safety and identify serious adverse events.METHODS: The PubMed database was searched for randomized controlled influenza human challenge studies with predetermined search terms. Review papers, papers without outcomes, community-acquired infections, duplicated data, pathogenesis studies, and observational studies were excluded.RESULTS: Twenty-six randomized controlled trials published between 1947 and 2014 fit the study inclusion criteria. Two-thirds of these trials investigated antivirals and one-third investigated influenza vaccines. Among 2462 subjects inoculated with influenza virus, the incidence of serious adverse events was low (0.04%). These challenge studies helped to down-select three antivirals and one vaccine that were subsequently approved by the US Food and Drug Administration (FDA).CONCLUSIONS: Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly and are cost-effective and safe, with a low incidence of serious adverse events.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Hälsovetenskap Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi hsv//swe
MEDICAL AND HEALTH SCIENCES Health Sciences Public Health, Global Health, Social Medicine and Epidemiology hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Infektionsmedicin hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Infectious Medicine hsv//eng
Influenza
Randomized controlled trials
Challenge studies
Controlled human infection
Influenza vaccine
Influenza therapeutics

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Wilder-Smith, AnneliesLee Kong Chian School of Medicine, Nanyang Technology University, Singapore 308232, Singapore(Swepub:umu)anwi0099 (author)
Lee Kong Chian School of Medicine, Nanyang Technology University, Singapore 308232, Singapore (creator_code:org_t)

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In:International Journal of Infectious Diseases: Elsevier49, s. 18-291201-97121878-3511

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