The main objective of this study is to investigate the effectiveness of the humeral and cellular immune response after tetanus revaccination in patients with AChR MG, MuSK MG, or LEMS. The secondary objective is to determine if revaccination induces…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Raise in total tetanus specific tetanus serum IgG titer in patients with AChR
MG, MuSK MG, or LEMS. A change in QMG composite score and MG ADL at 1 month
after revacinnation .
Secondary outcome
Secondary endpoints are a change in the QMG, or QMG composite score and/or a
changes in MG-ADL at 3 months after revaccination and a change in autoimmune
antibody titers against AChR, MuSK or VGCC at 1 month after revaccination.
Background summary
Myasthenia gravis (MG) and Lambert-Eaton myasthenic syndrome are neuromuscular
disorders in which functional acetylcholine receptors (AChR or MuSK)
respectively voltage-gated calcium channels (VGCC) become depleted at
neuromuscular junction due to an antibody-mediated autoimmune attack on the
neuromuscular synapse. Patients are at an increased risk of infection due to
the immunosuppressive therapy, while at the same time vaccination might be less
effective. Despite the common use of immunosuppressive treatment in these
patients, little is known about the effectiveness and safety of vaccination in
these patients. Tetanus is a frequently used vaccine with a well know safety
profile in healthy persons, but about the effectiveness and safety in
myasthenic patients little is known. The expected side effects are redness at
the injection site, muscle ache and fever. The side effects will be recorded
during the study.
Study objective
The main objective of this study is to investigate the effectiveness of the
humeral and cellular immune response after tetanus revaccination in patients
with AChR MG, MuSK MG, or LEMS. The secondary objective is to determine if
revaccination induces immunological or clinical exacerbation in patients with
AChR MG, MuSK MG, or LEMS
Study design
The study is a longitudinal experimental study. Blood samples and
questionnaires will be used.
Intervention
The effect of the revaccination will be investigated by testing for tetanus
specific serum IgG titer subclass, change in autoimmune antibody-titers and the
tetanus specific T-cell immune response. Furthermore, the effect of treatment
will be measured both objectively (Myasthenia Gravis Composite scale (MG
composite)) and QMG) and subjectively (Myasthenia Gravis-Activities of Daily
Living (MG-ADL) profile. The Quality of life questionnaire (MG-QOL15) will be
validated. Adverse effects will be measured by a symptom questionnaire.
Patients will continue to use their pre-study dose of pyridostigmine or
prednisone or other immunosuppressive treatment throughout this study.
Study burden and risks
One week before the vaccination the patient will fill out the MG-QOL15 en SF-36
questionnaire at home. At the day of revaccination the patient will stay 4
hours at the hospital. Vital signs are measured after therevaccination. The MG
composite, MG-ADL, SF-36 and MG-QOL15 questionnaire will be completed before
the revaccination. All patients will fill in the symptom questionnaire 4 weeks
after revaccination. At 4 weeks the patient will visit the hospital to draw a
blood sample and fill out the MG-ADL, SF-36 and MG-QOL15 questionnaire. The MG
composite en MG-ADL will be taken by the investigator. Three months after the
revaccination the patient will fill in the MG-QOL15, SF-36 and MG-ADL
questionnaire. Adverse effects of the revaccination include redness at the
injection site, muscle ache and fever. These will be recorded and monitored
throughout the trial.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Adult patients with myasthenia gravis or lambert eaton myasthenic syndrome based on
a) clinical signs or symptoms suggestive of myasthenia gravis or lambert eaton (for example, slowly progressive fluctuating muscle weakness in specific muscle groups); and a positive serologic test for acetylcholine recepter (AChR) antibodies or muscle specific receptor tyrosine kinase antibodies (MuSK) or voltage-gated calcium channel antibodies (VGCC).
b) patients with prednisone dose lower than 30mg and stable (dose +/-5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged. ;2. Males and females aged between 18 years and 65 years at the time of the injection.
Exclusion criteria
1. Received no previous tetanus vaccination in the childhood age or received a revaccination in de past year.
2. Myasthenic crisis in the last 3 months.
3. Presence of a thymoma or a planned thymectomy during the study period or within 12 months prior to the first dose of the tetanus toxoid booster immunization.
4. History or evidence of intravenous immunoglobulines or plasmapheresis within 3 months prior to the tetanus toxoid booster immunization.
5. Received a influenza vaccination 1 month before the tetanus revaccination.
6. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to
7. The investigator can exclude patients for this trial which are deemed not suitable for any reason.
8. Use of vitamin K antagonist or the new oral coagulantia (NOACS)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004344-35-NL |
| CCMO | NL50993.058.14 |