Viral Titre Determination in Healthy Subjects challenged with RSV

• Research type

  Research Study

• Full title

  An Exploratory, Open-label Study to Compare Nasopharyngeal Swabs and Nasal Washes in Healthy Subjects Challenged with Respiratory Syncytial Virus (RSV)

• IRAS ID

  163029

• Contact name

  Bryan Murray

• Contact email

  b.murray@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 up to 8 healthy subjects challenged with Respiratory Syncytial Virus (RSV-A Memphis 37b). The subjects will be healthy male and/or female subjects aged 18-45 years inclusive who meet the study eligibility criteria. Additional subjects will be held as reserves to replace subjects who become ineligible for the study between the admission day to quarantine, and the final assessment on Day 0. Each subject will be in the study for about 240 days from the Screening visit to their last follow-up visit.

  The study consists of three parts:
  Screening
  Quarantine
  Follow-up

  Screening will take place between 56 and 3 days prior to inoculation on Day 0. During screening visits volunteers will be asked to complete informed consents and undergo screening assessments to determine their eligibility to enter the study.

  If a volunteer is suitable they will enter quarantine up to two days prior to challenge virus inoculation, thereafter they will reside in the Quarantine Unit for a total of 15 days (from Day -2 to Day 12, with inoculation on Day 0). The volunteers will remain in quarantine until discharge day on Day 12. Volunteers may be asked to extend their stay in the quarantine unit if symptoms are still present on Day 12.

  Volunteers will attend a follow-up visit on Day 35 (+/- 3 days) post inoculation. Each volunteer will be assessed by the Investigator for ongoing symptoms and adverse effects. If an adverse event is unresolved at the follow-up visit, the volunteer may be asked to return for further follow-up visits until it has been resolved. Subjects whose samples are deemed suitable for virus propagation may be asked to attend a second follow-up visit 6 months after inoculation (+/- 2 weeks).

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/1134

• Date of REC Opinion

  10 Oct 2014

• REC opinion

  Further Information Favourable Opinion