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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011523-31-GB

Enrollment

Registered

2009-04-16

Start date

2009-06-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10046859 Term: Vaccination

Interventions

Trade Name: Menitorix Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: Pneumovax II Pharmaceutical Form: Solution for injection Trade Name: REVAXIS Pharmaceutical Form

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026