Immune response to vaccination following a possible treatment for MS

• Research type

  Research Study

• Full title

  A 3-month blinded, randomized, multicenter, placebo-controlled study to evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus toxoid booster injection in patients with relapsing forms of multiple sclerosis

• IRAS ID

  56035

• Contact name

  Richard Leaback

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-019028-30

• ISRCTN Number

  Not available

• Research summary

  Multiple Sclerosis (MS) is the most common disabling disease of the central nervous system (brain and spinal cord) in young adults.The cause of MS is unknown. It is an auto-immune disease, where the white blood cells (lymphocytes) start to attack the nerves and parts of the brain.There are several types of MS - the most common type is known as relapsing remitting MS (RRMS). Patients with RRMS have repeated acute episodes of neurological symptoms (relapses), which are followed by a complete of partial recovery (remission).Fingolimod (the study drug) is a possible new treatment for MS. It is taken once daily as a tablet. Fingolimod acts on the white blood cells responsible for immune reactions and make cells move away from the sites of inflammation. The white blood cells are redirected to the lymph nodes and othe places where they normally rest. Previous studies with fingolimod showed a significant decrease in the number of relapses per patient.The main purpose of this study is to look at the effects of fingolimod on the immune response after seasonal flu and tetanus booster vaccinations in patients with RRMS. Patients who sign consent and meet inclusion criteria will undergo examinations to determine that they are eligible to join the study. Patients will have a two in three chance of receiving active treatment and a one in three chance of receiving placebo (dummy drug, no active ingredient). After at least six weeks of taking study medication, patients will receive the seasonal flu vaccine and a tetanus booster.Each patient will visit the clinic at least eight times over a 16 week period (including a 4 weeks screening phase)

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/36

• Date of REC Opinion

  30 Jul 2010

• REC opinion

  Further Information Favourable Opinion