umu.sePublikationer
Ändra sökning
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf
Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies
Lee Kong Chian School of Medicine, Nanyang Technology University, Singapore 308232, Singapore.
2016 (Engelska)Ingår i: International Journal of Infectious Diseases, ISSN 1201-9712, E-ISSN 1878-3511, Vol. 49, s. 18-29Artikel, forskningsöversikt (Refereegranskat) Published
Abstract [en]

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.

Ort, förlag, år, upplaga, sidor
Elsevier, 2016. Vol. 49, s. 18-29
Nyckelord [en]
Influenza, Randomized controlled trials, Challenge studies, Controlled human infection, Influenza vaccine, Influenza therapeutics
Nationell ämneskategori
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi Infektionsmedicin
Identifikatorer
URN: urn:nbn:se:umu:diva-127475DOI: 10.1016/j.ijid.2016.05.013ISI: 000380806600003PubMedID: 27208631OAI: oai:DiVA.org:umu-127475DiVA, id: diva2:1046473
Tillgänglig från: 2016-11-14 Skapad: 2016-11-14 Senast uppdaterad: 2018-06-09Bibliografiskt granskad

Open Access i DiVA

Fulltext saknas i DiVA

Övriga länkar

Förlagets fulltextPubMed

Personposter BETA

Wilder-Smith, Annelies

Sök vidare i DiVA

Av författaren/redaktören
Wilder-Smith, Annelies
I samma tidskrift
International Journal of Infectious Diseases
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologiInfektionsmedicin

Sök vidare utanför DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetricpoäng

doi
pubmed
urn-nbn
Totalt: 211 träffar
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf