Assessment of Salmonella Typhim Vi Vaccine

• Research type

  Research Study

• Full title

  Assessment of Salmonella Typhim Vi(TM) vaccine (Sanofi Pasteur MSD) for the investigation of selective antibody deficiency to polysaccharide.

• IRAS ID

  10381

• Contact name

  Berne Ferry

• Sponsor organisation

  Oxford Radcliffe Hospital NHS Trust

• Eudract number

  2010-018596-24

• ISRCTN Number

  Not appplicable

• Research summary

  The outer surfaces of bacteria contain sugars (known as polysaccharides) which are important for signalling to the immune system that bacteria are present and telling antibodies to come and remove the bacteria. Everybody carries antibodies in their blood; however people who can only make very small amounts of antibody have a disease called Primary Antibody Deficiency PAD. Such patients have serious recurrent bacterial infections due to their low antibody levels. An important investigation in suspected PAD is to see whether the patient makes an antibody response to bacterial polysaccharides. Traditionally, a vaccine against pneumococcal polysaccharides (Pneumovax) has been used to test this, however recently a new non polysaccharide version of this vaccine against pneumococcal disease (Prevenar) has been introduced and is rapidly taking over from Pneumovax, with the result that Pneumovax is likely to be withdrawn from the market. Typhim Vi - a pure polysaccharide vaccine against typhoid is safe and licensed for use in adults and children. Using Typhim Vi to test for immune responses to bacterial polysaccharides is supported in the literature and carried out in some clinics. However it is not common practice due to limited data being available for normal ranges for children and adults. We hope to generate this data by recruiting individuals pre and post Typhim Vi immunisation and measuring their ability to produce antibodies to typhoid by using a new test (ELISA)

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/75

• Date of REC Opinion

  24 Nov 2010

• REC opinion

  Further Information Favourable Opinion