The effect of tetanus revaccination in patients with myasthenia gravis

• Register: EUCTR
• Last refreshed on: 30 November 2020
• Main ID: EUCTR2014-004344-35-NL
• Date of registration: 16/02/2015
• Prospective Registration: Yes
• Primary sponsor: Leiden University Medical Center
• Public title: The effect of tetanus revaccination in patients with myasthenia gravis
• Scientific title: The effect of tetanus revaccination in patients with myasthenia gravis - Tetanus revaccination in patients with myasthenia gravis
• Date of first enrolment: 16/02/2015
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004344-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Tetanus study contact
• Affiliation: Leiden University Medical Center

• Name: Tetanus study contact
• Affiliation: Leiden University Medical Center

Key inclusion & exclusion criteria

Inclusion criteria:
1. Males and females aged between 18 years and 65 years at the time of the injection.
2. Patient with ocular or generalized AChR MG, MuSK MG or LEMS; and
3. A positive serologic test for AChR antibodies > 3 nmol/l or MuSK antibodies >0.1 nmol/l or VGCC antibodies >20 fmol/l.
4. Patient with prednisone dose lower than 30mg and stable (dose +/- 5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged.

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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Received no previous tetanus vaccination in the childhood age or received a revaccination in de past year.
2. MG patients of Grade 4 or 5 based on MGFA classification.
3. Myasthenic crisis in the last 3 months
4. Presence of a thymoma.
5. Planned thymectomy during the study period or within 12 months prior of the tetanus toxoid booster immunization.
6. Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
7. History or evidence of administration of immunoglobulins within 3 months prior to the tetanus revaccination.
8. History or evidence of plasmapheresis within 3 months prior to the tetanus revaccination.
9. At high risk for aspiration.
10. Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
11. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
12. History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
13. Severe hepatic, renal or cardiac insufficiency.
14. Major congenital defects or serious chronic illness other than MG.
15. Positive pregnancy test or desire to become pregnant during the study.
16. Influenza vaccination 1 month before the tetanus revaccination
17. The use of vitamine K antagonist or new coagulantia (NOAC's)
18. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
19. The investigator can exclude patients for this trial which are deemed not suitable for any reason.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Myasthenia gravis Lambert-Eaton myasthenic syndrome

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Tetanus vaccin
Product Name: Tetanus vaccin
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Primary end point(s): -Change in total tetanus specific serum IgG titer in patients with AChR MG, MuSK MG, or LEMS
-Change in MG composite score at 4 weeks after revaccination

Main Objective: To determine the effectiveness of the humeral and cellular immune response after tetanus revaccination in patients with AChR MG, MuSK MG, or LEMS.

Timepoint(s) of evaluation of this end point: 4 weeks after the revaccination

Secondary Objective: To determine if revaccination induces immunological or clinical exacerbation in patients with AChR MG, MuSK MG, or LEMS

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 4 and 12 weeks after the revaccination

Secondary end point(s): - Change in MG composite score at 12 weeks after revaccination
- Change in MG-ADL 4 and/or 12 weeks after revaccination
- Increase in the dose of any of the immunosuppressive drugs for treatment of the MG or LEMS during the 12 weeks of the study
- Change in tetanus specific serum IgG subclass titers in patients with AChR MG, MuSK MG, or LEMS
-Change in autoimmune antibody titers against AChR, MuSK or VGCC at 4 weeks after revaccination
-Change in tetanus specific T-cell immune response at 4 weeks after revaccination
- Validation of the MG-QOL15 in Dutch

Secondary ID(s)

50993

Source(s) of Monetary Support

FP7 EU project nr 110173

Ethics review

Status: Approved
Approval date: 16/02/2015
Contact: