Influenza H3N2 Characterisation Study

• Research type

  Research Study

• Full title

  A Randomised Double Blind Study to Characterise Influenza A/Perth/16/2009(H3N2) Virus for Use in Future Human Viral Challenge Studies

• IRAS ID

  133470

• Contact name

  Hosnieh Fathi

• Contact email

  h.fathi@retroscreen.com

• Sponsor organisation

  Retroscreen Virology Ltd

• Research summary

  This is a randomised double blind study in a total of up to 28 healthy subjects challenged with the Influenza A/Perth/16/2009(H3N2) virus in a Quarantine environment. Eligible subjects will be assigned to one of three/four virus titre groups (A,B,C and D (optional), each with up to eight subjects per group ; Approximately 6 subjects will be reserves.

  The study consists of three parts:
  Screening
  Quarantine
  Follow up

  Screening will take place between 56 to 3 days (Day -56 to Day -3) 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 Volunteers fulfill the eligibility criteria they will enter the quarantine environment on Day -2 or Day -1 prior to inoculation day and will be assigned to one of three/four virus dilution groups (1(A), 2(B), 3(C), or 4(D, optional)). The subjects will remain in the quarantine unit until discharge day on Day 8 (if symptoms have resolved). Subjects may be required to extend their stay in the quarantine unit if symptoms are still present on Day 8.

  Subjects will be required to attend follow up visits on Day 18 (+/- 2 days) and Day 28 (+/- 5 days) post inoculation. Each subject will be assessed by the Investigator for on-going symptoms and adverse effects. Any adverse events that are unresolved at Day 28 (+/- 5 days) follow up visit may necessitate further follow-up visits up to 60 days post inoculation (is this time window of 60 days still listed in the SDD/protocol) , with onward referral to an appropriate medical team as required.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/0911

• Date of REC Opinion

  15 Aug 2013

• REC opinion

  Further Information Favourable Opinion