A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC

• Conditions: The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.; MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosis; MedDRA version: 9.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10046859Term: Vaccination

• Registration Number: EUCTR2009-011523-31-GB
• Lead Sponsor: R & D, Cambridge University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive)
•Diagnosis of MS using the McDonald’s criteria10
•Received alemtuzumab at least 4 weeks previously
•If receiving Revaxis must have been previously vaccinated against tetanus (for the tetanus vaccine to stimulate the desired recall response)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previously received Haemophilus b or pneumococcal vaccines or have had Haemophilus or pneumococcal disease (these antigens are intended to be novel to the subject’s immune system)
•Allergy to a component in any of the vaccines
•Previous or current immune thrombocytopaenic purpura (ITP) or haemolytic anaemia.
•Received a diphtheria or tetanus toxoid vaccine within the last 5 years; only applicable if the patient will be given Revaxis (vaccination recommended after 5 years to minimise adverse events)
•Guillain-Barré syndrome or brachial neuritis due to a previous vaccine
•Acute severe febrile illness

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the trial is to determine if vaccinations are effective in patients with multiple sclerosis who have been treated with the lympho-depleting humanised monoclonal antibody alemtuzumab. The primary outcome measure will be the antibody response to each vaccine measured at 4 weeks post-vaccination.;Secondary Objective: The secondary outcome measures will be the level of antibodies to measles, mumps, rubella, varicella zoster and Epstein-Barr viruses, before and after treatment and the effect of vaccination on lymphocyte reconstitution. ;Primary end point(s): The primary outcome measure will be the antibody response to each vaccine measured at 4 weeks (+/- 7 days) post-vaccination.