ChAdOx1-NP+M1 dose escalation study

• Research type

  Research Study

• Full title

  A phase I study to determine the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1

• IRAS ID

  99648

• Contact name

  Adrian V S Hill

• Sponsor organisation

  Oxford University Hospitals NHS Trust

• Eudract number

  2012-000641-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate flunza vaccine ChAdOx1-NP. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3" study plan (described further in later sections). Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0132

• Date of REC Opinion

  17 May 2012

• REC opinion

  Further Information Favourable Opinion