FP-01.1: first doses in humans; version 1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, ascending dose study to assess the safety, tolerability and immunogenicity of repeated intramuscular administration of an influenza A vaccine (FP-01.1) (HMR code 10-503)

• IRAS ID

  59036

• Contact name

  Steve Warrington

• Eudract number

  2010-020856-68

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  FP-01.1 is a new experimental vaccine against influenza A (flu). There are many strains of flu virus, and almost every year a new strain appears and causes an epidemic ?? recently it??s been H1N1 (swine flu). Existing flu vaccines don??t protect against all strains, and a new vaccine is needed each year as new strains develop. FP 01.1 targets a part of the virus that??s shared by most strains, so we expect it to have a broader protective effect than existing flu vaccines. We aim to find out if it??s safe and well tolerated, and how effectively it stimulates an immune reponse to flu.We'll recruit 48 healthy men and women aged 18??55 years, into 3 groups of 16. In each group, 12 participants will receive FP-01.1 and 4 will receive a dummy medicine (placebo). We'll inject a dose of FP-01.1 or placebo into a muscle in the upper arm on 3 occasions ?? on each occasion, Group 1 will receive 0.3 mg FP-01.1; Group 2 will receive 0.9 mg; and Group 3 will receive 3 mg. Each group will be divided into 2 bands (A and B). Participants in Band A will be injected 24 hours before those in Band B. They??ll stay in the research unit overnight after their first dose, and for 6-8 hours after subsequent doses. Band B participants will stay in the research unit for 6-8 hours after each dose. All participants will come to the research unit for outpatient visits between doses and for 6 months after the last dose. They??ll complete the study in 44 weeks.This study will take place at a specialist research centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth and from volunteer databases.Immune Targeting Systems (ITS) Ltd is funding the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/62

• Date of REC Opinion

  2 Aug 2010

• REC opinion

  Favourable Opinion