EUCTR2009-011523-31-GB
Active, not recruiting
Not Applicable
A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC
R & D, Cambridge University Hospitals0 sites60 target enrollmentApril 16, 2009
ConditionsThe 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 sclerosisMedDRA version: 9.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisMedDRA version: 9.1Level: LLTClassification code 10046859Term: Vaccination
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.
- Sponsor
- R & D, Cambridge University Hospitals
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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