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Clinical Trials/EUCTR2009-011523-31-GB
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

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.

Registry
who.int
Start Date
April 16, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
R & D, Cambridge University Hospitals

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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