CAM-VAC version 1.0

• Research type

  Research Study

• Full title

  A study of the immune response to vaccination in MS patients treated with alemtuzumab.

• IRAS ID

  20310

• Contact name

  Alasdair Coles

• Eudract number

  2009-011523-31

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a study of the efficacy of vaccination in patients with multiple sclerosis who have been treated with the investigational medicine, alemtuzumab.Alemtuzumab (previously known as Camapth-1H) is a therapeutic monoclonal antibody that causes long lasting depletion of T lymphocytes. It is licensed for the treatment of chronic lymphocytic leukaemia (CLL) and has been used as an experimental treatment of multiple sclerosis in Cambridge, UK, since 1991. The latest phase 2 trial, published in the NEJM in October 2008, demonstrated that it is the most effective treatment of multiple sclerosis to date, when given early in the relapsing-remitting phase of the illness. Two phase 3 trials, comparing alemtuzumab with standard licensed therapies are currently on-going. The issue of the effectiveness of vaccination and retained immunological memory to infections is important for patients with multiple sclerosis treated with alemtuzumab because: (i) they are young adults who may well be exposed to infections in young children or who require vaccinations for travel abroad however (ii) alemtuzumab produces a dramatic and profound lymphopaenia, which may compromise immunological memory or the ability to respond appropriately to a vaccination. It takes a median of 6 years before CD4 numbers are fully restored. There has been no previous study of the effectiveness of vaccinations after alemtuzumab treatment.We propose to test the effectiveness of three vaccines in patients who have received alemtuzumab as part of the approved phase 2 or phase 3 trials: 1. Menitorix; a Haemophilus flunzae type b and Meningococcal group C vaccine (T-dependent neo-antigens)2. Pneumovax II; a pneumococcal capsular polysaccharide vaccine (T-cell independent antigen)3. Revaxis; a vaccine containing tetanus toxoid, diphtheria toxoid and inactivated polio (T-dependent recall antigens). These are inactivated or subunit vaccines, which are considered safe in immunocompromised patients.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/64

• Date of REC Opinion

  28 May 2009

• REC opinion

  Further Information Favourable Opinion