A Study to Explore Candidate Biomarkers Relating to RSV Challenge

• Research type

  Research Study

• Full title

  A Study to Explore Candidate Biomarkers Relating to Respiratory Viral Disease and Susceptibility to Infection in Healthy Volunteers Challenged with Respiratory Syncytial Virus (RSV)

• IRAS ID

  166099

• Contact name

  Hosnieh Fathi

• Contact email

  h.fathi@retroscreen.com

• Sponsor organisation

  Retroscreen Virology Ltd.

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This is an open-label healthy volunteer Human Viral Challenge study, in which volunteers will be inoculated with the challenge virus via the nostrils. The virus is a strain of Respiratory Syncytial Virus (RSV) - a common virus that can cause severe disease in infants and young children. The study population will consist of up to 100 healthy male and/or female volunteers aged 18-55 years who meet the eligibility criteria. Sufficient replacement volunteers will be recruited to ensure 100 evaluable volunteers. Each volunteer will be enrolled on the study for approximately 85 days, from the Screening Visit to their final Follow-Up Visit. The study will consist of three phases:

  Screening
  Quarantine
  Follow-Up

  Screening will take place from 56 days to 3 days prior to inoculation with the study virus on Day 0. During their screening visit, volunteers will be required to complete informed consent forms and undergo scheduled medical assessments to determine their eligibility.

  If volunteers meet the eligibility criteria they will enter the Quarantine Unit two days prior to inoculation. Thereafter, volunteers will reside on the Unit for a total of approximately 14 days (from Day -2 to Day 12) before being discharged. If volunteers remain symptomatic on Day 12 they may be required to extend their stay until such symptoms resolve.

  Volunteers will then be required to attend follow-up visits on Day 20 (± 1 day) and Day 28 (± 3 days) post-inoculation. Each volunteer will be assessed by the investigator for ongoing symptoms and adverse events (AEs). The volunteer may be asked to return for a subsequent appointment if symptoms/AEs are unresolved after the last follow-up visit on Day 28.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/1245

• Date of REC Opinion

  27 Nov 2014

• REC opinion

  Favourable Opinion