Exploratory study of Respiratory Viral Disease in Healthy Subjects

• Research type

  Research Study

• Full title

  A Study to Explore Candidate Biomarkers and Drug Targets Relating to Respiratory Viral Disease and Susceptibility to Infection in Healthy Volunteers Challenged with Influenza Virus

• IRAS ID

  156173

• Contact name

  Samuel Israel

• Contact email

  s.israel@retroscreen.com

• Sponsor organisation

  Retroscreen Virology Ltd

• Clinicaltrials.gov Identifier

  n/a, n/a

• Research summary

  This is an open-label healthy volunteer Human Viral Challenge study with a total of 30 healthy subject challenged with the influenza A/Perth/16/2009(H3N2) virus in two or more quarantine group. Healthy male and/or female subjects aged 18-55 years inclusive who meet the study eligibility criteria. Additional subjects will be held as reserves for each quarantine group to replace subjects who become ineligible for the study between the day of admission to quarantine and the final assessment. Each subject will be in the study for about 85 days or 12 weeks from the Screening visit to their last follow-up visit.

  The study consist of three parts:
  Screening
  Quarantine
  Follow up

  Screening will take place between 56 to 3 days prior to inoculation with (influenza A/Perth/16/2009(H3N2) on Day 0. During screening visits volunteers will be asked to complete informed consents and undergo scheduled screening assessments to determine their eligibility to enter the study.

  If volunteer fulfil the eligibility criteria they will enter the quarantine environment two days prior to the inoculation, thereafter they will be resident in the Quarantine Unit for a total of approximately 11 days (from Day -2 to Day 8, with Challenge virus inoculation on Day 0). The volunteers will remain in the Quarantine Unit until discharge day on Day 8 (if symptoms have been resolved). Volunteers may be required to extend their stay in the quarantine unit if symptoms are still present on Day 8.

  Volunteers will be required to attend follow up visits on Day 15 (+/1 days) and Day 28 (+/3 days) post inoculation. Each volunteer will be assessed by the Investigator for ongoing symptoms and adverse effects. Any adverse events that are unresolved at Day 28 (+/3 days) follow-up visit, the volunteer may be asked to return for further follow up visits until the adverse event has been resolve.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/1107

• Date of REC Opinion

  10 Oct 2014

• REC opinion

  Further Information Favourable Opinion