ADITEC FLU STUDY: Understanding the genetic basis for immune responses

• Research type

  Research Study

• Full title

  A phase II, multi-centre, open labelled randomised control trial to describe immune & transcriptomic responses to trivalent inactivated vaccine (TIV) & MF59 adjuvanted influenza vaccine (ATIV) in 14 -26 month healthy children

• IRAS ID

  103808

• Contact name

  Andrew J Pollard

• Eudract number

  2012-002443-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Infants and young children do not respond as well as adults to thfluvaccines currently available in the UKflud, is a different type of flunza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59. This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are ??switched on?? in response to immunisation, and to see how this differs from the response to currently usefluvaccines. To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the flunza vaccine with the MF59 adjuvant (ATIV) or one of the flunza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against flunza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects. The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0407

• Date of REC Opinion

  1 Aug 2012

• REC opinion

  Favourable Opinion