Safety, tolerability and efficacy of the influenza candidate, FLU-v

• Research type

  Research Study

• Full title

  A RANDOMISED DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 1B TRIAL TO EVALUATE THE SAFETY, TOLERABILITY AND PROTECTIVE EFFICACY OF THE INFLUENZA VACCINE CANDIDATE, FLU-V, IN AN INFLUENZA CHALLENGE MODEL

• IRAS ID

  37417

• Contact name

  Anthony Saul Gilbert

• Sponsor organisation

  PepTcell Ltd

• Eudract number

  2009-014716-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  If subjects participate in this study, they will be required to attend a screening visit, a vaccination visit and a 10-11 day overnight stay in a quarantine facility, followed by one follow-up visit to the Retroscreen clinic. The expected total duration of their participation in this study from screening through to follow-up is up to 4 months. Retroscreen will recruit up to 44 volunteers to be enrolled and vaccinated with thfluv experimental vaccine or a placebo. A placebo is a dummy vaccine which looks like the real thing but contains no active ingredient. The placebo to be used in this study is a mixture of water, mineral oil and surfactant. These same ingredients are also present as part of the experimental vaccine. Three weeks after being vaccinated witfluv or placebo, 30 subjects will be taken to a Quarantine Unit to be exposed to the H3N2 study virus and then monitored by Retroscreen study physicians and nurses for a 10-11 day period. The other 14 volunteers will be held in reserve as back-ups. If fewer than 30 of the subjects who travel to the Quarantine Unit are eligible to be exposed to the study virus, then subjects who have been kept in reserve will be used. Following discharge from the Quarantine Unit, subjects will attend one study follow-up visit, 28 days after exposure to the study virus. Assessments will take place and samples will be taken from subjects.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/1

• Date of REC Opinion

  26 Apr 2010

• REC opinion

  Further Information Favourable Opinion