Randomized, Double-Blind, Placebo-Controlled Study in Norwalk Virus

• Research type

  Research Study

• Full title

  Phase 1-2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study in Healthy Adults of Intranasal Norwalk Virus-like Particle Vaccine in Experimental Human Norwalk Virus Infection

• IRAS ID

  25851

• Eudract number

  2009-012285-31

• ISRCTN Number

  n/a

• Research summary

  The aim of the study is to determine whether or not an inhaled investigational medicinal product (Norwalk VLP Vaccine) is effective and safe as a treatment for Norwalk Virus. To see if this works effectively we will ask up to 80 volunteers (two groups: 40 IMP and 40 placebo) to take 100 æg of the vaccine and compare the effects to those who receive mannitol and sucrose (placebo/dummy). All eligible volunteers will be infected with a mild strain of Norwalk Virus Lot 4239 (from NIH, BB-IND # 10255) delivered orally at 48 RT-PCR units. They will be asked to remain in a quarantine facility with trained medical staff. They are not allowed to mix with other members of the public until the study is complete. The volunteers will remain inpatients for 4 days (maximum of 7 days if showing any symptoms of Norwalk Virus on the planned discharge day).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/92

• Date of REC Opinion

  29 Oct 2009

• REC opinion

  Further Information Favourable Opinion