Multiple Sclerosis Tetanus Vaccine for Reduction of Inflammation-1

• Research type

  Research Study

• Full title

  The Effects of Tetanus Vaccination on Mediators of Autoimmunity in Patients with Multiple Sclerosis

• IRAS ID

  29045

• Contact name

  Cris S Constantinescu

• Eudract number

  2007-001496-11

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple sclerosis (MS) is a leading cause of neurological disability in adults. It is an immune mediated injury to the nerve fibres in the brain and spinal cord and their myelin sheath. There is faulty regulation of the immune system including a deficit of immune cells, called regulatory T cells (Treg cells) that normally prevent or dampen inflammation. Studies show that tetanus vaccination reduces the risk of getting MS or having an MS relapses. The mechanisms of this protection are unclear. We think that the vaccine stimulates Treg cells and that this is responsible for this protective effect. In a pilot study in healthy volunteers, we demonstrated the safety of tetanus vaccination, and there is suggestion that some subjects have increased Treg cells. In this study, we plan to vaccinate 46 MS patients with tetanus (part of the DTP vaccine together with diphtheria and polio) or placebo and follow the number and function of Treg cells over 1 year. Over this time, we will also have the opportunity to follow the clinical course of MS.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/106

• Date of REC Opinion

  23 Dec 2009

• REC opinion

  Further Information Favourable Opinion