FIM Study of an Influenza Vaccine Candidate

• Research type

  Research Study

• Full title

  A Single Centre, Randomised, Double Blind, Phase I Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)

• IRAS ID

  23723

• Sponsor organisation

  PepTcell Limited

• Eudract number

  2009-013910-28

• Research summary

  The new flunza vaccine candidate being investigated in this first-in-man study is being developed to provide a single treatmenfluvaccine which is effective against all strains ofluvirus. The new vaccine candidate targets distinctive markers that have been identified as being present on mosfluviruses giving long-term protection against the threat of new strains. This could eliminate the need for annuafluvaccinations.The purpose of this study is to:* Determine the safety and tolerability of two dose levels of the new vaccine when given with and without adjuvant (a substance added to a vaccine to improve the immune response so that less vaccine's needed to provide protection). * Determine the body's immune response to two dose levels of the new vaccine when given with and without adjuvant.Placebo will be given to some volunteers during the study to ensure that any side effects are judged fairly. Volunteers will take part in only one dose level and will receive a single 1 ml subcutaneous injection of their assigned dose level in the abdomen. A total of 48 male volunteers will take part in this study (24 will take part in each dose level with 20 receiving active treatment and 4 receiving placebo). As a precautionary measure, dosing will be staggered (2 volunteers dosed at 0 hour, 2 volunteers dosed at hours and the remainder dosed at hours in each dose level, providing the safety review of preceding groups is satisfactory). The first dose level must be completed and have a satisfactory safety review before dosing at the second dose level can begin.The maximum duration of the study (from screening until final visit) could be up to 42 days for each volunteer.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/18

• Date of REC Opinion

  22 Feb 2010

• REC opinion

  Further Information Favourable Opinion