Placebo-controlled study of intravenous MEDI-557 against RSV

• Research type

  Research Study

• Full title

  A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged with Respiratory Syncytial Virus (RSV)

• IRAS ID

  87491

• Contact name

  Anthony Gilbert

• Sponsor organisation

  Medimmune

• Eudract number

  2011-003370-83

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  A randomised, double-blind, placebo-controlled study assessing the effects of the study drug, MEDI-557, on healthy adult volunteers exposed to Respiratory Syncytial Virus (RSV) during a 17-18 day quarantine period. Approximately 300 volunteers will be screened to identify 30 subjects who will be dosed with RSV-A Memphis 37 and monitored by medical staff during the quarantine phase of the study. At the screening visit, subjects will have a blood test to detect antibodies to RSV if this has not been done within 5 months prior to study virus exposure. Subjects with low levels of immunity to RSV will be enrolled into the study. These volunteers will attend a Study specific screening visit which will be repeated on Day ?? 2.On Day ?? 2 eligible volunteers will attend the Quarantine Unit. Volunteers will be tested for the presence of different viruses; volunteers confirmed as being positive will be excluded from the study. Volunteers will be excluded if they have a fever or ??cold oflulike? symptoms between arrival at the Quarantine Unit and the day of study virus administration. The study physician will provide a referral for medical care if necessary. Eligible volunteers will be randomized to receive MEDI-557 or placebo. This will occur three days after entering the Quarantine Unit on study Day 1. Volunteers will receive the study virus five days after entering the Quarantine Unit on study Day 3. They will remain in quarantine for another 12 days (or 13 days or longer if a volunteer still tests positive for RSV at study Day 15). It is rare for a volunteer to stay for longer than this.Following discharge from quarantine, volunteers will attend a follow-up visit, approximately 28 days after exposure to the study virus. Following discharge from the Quarantine Unit, volunteers will attend regular study follow-up visits through to Day 360.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0144

• Date of REC Opinion

  18 Oct 2011

• REC opinion

  Further Information Favourable Opinion