tetano
Editor, Senior Moderator
Int J Infect Dis. 2016 May 18. pii: S1201-9712(16)31056-6. doi: 10.1016/j.ijid.2016.05.013. [Epub ahead of print]
[h=1]Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies.[/h] Balasingam S[SUP]1[/SUP], Wilder-Smith A[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] 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. We performed a systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform. Our primary objective was to document the scope of trials to-date and the main efficacy outcome in the trials. Our secondary objective was to assess safety and identify serious adverse events.
[h=4]DESIGN:[/h] We searched PubMed for randomized influenza controlled human challenge studies with predetermined search terms. We excluded review papers, papers without outcomes, community acquired infections, duplicated data, pathogenesis studies and observational studies.
[h=4]RESULTS:[/h] Between 1947 and 2014, 26 randomized controlled trials fit our inclusion criteria. Two thirds of these trials investigated antivirals and one-third influenza vaccines. Among 2,462 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 FDA approved.
[h=4]CONCLUSION:[/h] Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly, are cost effective and safe with low serious adverse events incidence.
Copyright ? 2016. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] challenge studies; controlled human infection; influenza; influenza vaccine influenza therapeutics; randomized controlled trials
PMID: 27208631 [PubMed - as supplied by publisher] Free full text
[h=1]Randomized controlled trials for influenza drugs and vaccines: a review of controlled human infection studies.[/h] Balasingam S[SUP]1[/SUP], Wilder-Smith A[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVES:[/h] 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. We performed a systematic review of randomized controlled trials of countermeasures for influenza that used the experimental human infection platform. Our primary objective was to document the scope of trials to-date and the main efficacy outcome in the trials. Our secondary objective was to assess safety and identify serious adverse events.
[h=4]DESIGN:[/h] We searched PubMed for randomized influenza controlled human challenge studies with predetermined search terms. We excluded review papers, papers without outcomes, community acquired infections, duplicated data, pathogenesis studies and observational studies.
[h=4]RESULTS:[/h] Between 1947 and 2014, 26 randomized controlled trials fit our inclusion criteria. Two thirds of these trials investigated antivirals and one-third influenza vaccines. Among 2,462 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 FDA approved.
[h=4]CONCLUSION:[/h] Controlled human infection studies are an important research tool in assessing promising influenza vaccines and antivirals. These studies are performed quickly, are cost effective and safe with low serious adverse events incidence.
Copyright ? 2016. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] challenge studies; controlled human infection; influenza; influenza vaccine influenza therapeutics; randomized controlled trials
PMID: 27208631 [PubMed - as supplied by publisher] Free full text