Ellen Strijbos1, Maartje G Huijbers2, Inge E van Es3, Iris Alleman4, Monique M van Ostaijen-Ten Dam5, Jaap Bakker6, Erik W van Zwet7, Cornelia M Jol-van der Zijde5, Maarten D van Tol5, Jan J Verschuuren8. 1. Department of Neurology, Leiden University Medical Centre, The Netherlands. Electronic address: e.strijbos@lumc.nl. 2. Department of Neurology, Leiden University Medical Centre, The Netherlands; Department of Human Genetics, Leiden University Medical Centre, The Netherlands. 3. Department of Human Genetics, Leiden University Medical Centre, The Netherlands. 4. Department of Physiotherapy, Leiden University Medical Centre, The Netherlands. 5. Department of Paediatrics, Laboratory of Immunology, Leiden University Medical Centre, The Netherlands. 6. Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, The Netherlands. 7. Department of Medical Statistics and Bioinformatics, Leiden University Medical Centre, The Netherlands. 8. Department of Neurology, Leiden University Medical Centre, The Netherlands.
Abstract
OBJECTIVE: To investigate the humoral immune response to and safety of a tetanus revaccination in patients with myasthenia gravis or Lambert-Eaton myasthenic syndrome. METHODS: A tetanus revaccination was administered to 66 patients. Before and 4weeks after revaccination a blood sample and clinical outcome scores were obtained. Anti-tetanus IgG total, IgG1 and IgG4 titres were measured with an ELISA and disease-specific antibody titres (AChR, MuSK or VGCC) with a radio-immunoprecipitation assay. A historic healthy control group was used for comparing tetanus antibody titres with that of our patients. A placebo (saline) vaccination group was used to investigate the variability of clinical outcome scores with a 4weeks interval. RESULTS: In 60 of 65 patients, a significant increase of the anti-tetanus antibody response was measured. Thymectomy did not have an impact on this responsiveness. Patients with immunosuppressive medication had a significantly lower pre and post titre compared to healthy controls, but their response was still significant. The titres of disease-specific antibodies were unchanged 4weeks after revaccination. The clinical outcome scores showed no exacerbation of symptoms of the disease. CONCLUSION: A tetanus revaccination in patients with myasthenia gravis or Lambert-Eaton myasthenic syndrome is safe and induces a significant immune response, irrespectively of their immunosuppressive medication. We observed neither immunological nor clinical relevant exacerbations associated with the tetanus revaccination. CLINICAL TRIAL REGISTRY: The tetanus trial is listed on clinicaltrialsregister.eu under 2014-004344-35. The placebo AChR MG group was part of another clinical trial, investigating influenza vaccination in myasthenic patients. This trial is listed on clinicaltrialsregister.eu under 2016-003138-26.
RCT Entities:
OBJECTIVE: To investigate the humoral immune response to and safety of a tetanus revaccination in patients with myasthenia gravis or Lambert-Eaton myasthenic syndrome. METHODS: A tetanus revaccination was administered to 66 patients. Before and 4weeks after revaccination a blood sample and clinical outcome scores were obtained. Anti-tetanus IgG total, IgG1 and IgG4 titres were measured with an ELISA and disease-specific antibody titres (AChR, MuSK or VGCC) with a radio-immunoprecipitation assay. A historic healthy control group was used for comparing tetanus antibody titres with that of our patients. A placebo (saline) vaccination group was used to investigate the variability of clinical outcome scores with a 4weeks interval. RESULTS: In 60 of 65 patients, a significant increase of the anti-tetanus antibody response was measured. Thymectomy did not have an impact on this responsiveness. Patients with immunosuppressive medication had a significantly lower pre and post titre compared to healthy controls, but their response was still significant. The titres of disease-specific antibodies were unchanged 4weeks after revaccination. The clinical outcome scores showed no exacerbation of symptoms of the disease. CONCLUSION: A tetanus revaccination in patients with myasthenia gravis or Lambert-Eaton myasthenic syndrome is safe and induces a significant immune response, irrespectively of their immunosuppressive medication. We observed neither immunological nor clinical relevant exacerbations associated with the tetanus revaccination. CLINICAL TRIAL REGISTRY: The tetanus trial is listed on clinicaltrialsregister.eu under 2014-004344-35. The placebo AChR MG group was part of another clinical trial, investigating influenza vaccination in myasthenicpatients. This trial is listed on clinicaltrialsregister.eu under 2016-003138-26.