Flu vaccine in patients with Myasthenia Gravis

• Register: EUCTR
• Last refreshed on: 24 October 2016
• Main ID: EUCTR2016-003138-26-NL
• Date of registration: 08/08/2016
• Prospective Registration: Yes
• Primary sponsor: LUMC
• Public title: Flu vaccine in patients with Myasthenia Gravis
• Scientific title: Influenza vaccination in patients with Myasthenia Gravis - Influenza vaccine in Myasthenia Gravis
• Date of first enrolment: 04/10/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003138-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• 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: Influenza study contact
• Affiliation: LUMC

• Name: Influenza study contact
• Affiliation: LUMC

Key inclusion & exclusion criteria

Inclusion criteria:
1. Males and females aged above 18 years at the time of the injection.
2. Patient with ocular or generalized AChR MG and
3. A positive serologic test for AChR antibodies > 0.5 nmol/l in the past
4. Patient with prednisone dose lower than 30mg and stable (dose +/- 5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged.
5. A healthy control above 18 years at the time of injection with no immunosuppressive medication.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion criteria:
1. MG patients with a severe form of MG (Grade 4 or 5 based on MGFA classification).
2. Myasthenic crisis in the last 3 months
3. Presence of a thymoma.
4. Planned thymectomy during the study period or within 12 months prior of the tetanus toxoid booster immunization.
5. 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.
6. History or evidence of administration of immunoglobulins within 3 months prior to the tetanus revaccination.
7. History or evidence of plasmapheresis within 3 months prior to the tetanus revaccination.
8. At high risk for aspiration.
9. Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
11. History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
12. Severe hepatic, renal or cardiac insufficiency.
13. Major congenital defects or serious chronic illness other than MG.
14. Pregnancy or desire to become pregnant during the study.
15. Use of vitamin-K antagonist or new anti-coagulants (NOACS)
16. 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.
17. 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

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

Intervention(s)

Trade Name: Influenza vaccine
Product Name: Influenza vaccine
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Secondary Objective: The secondary objectives are to determine if vaccination induces immunological or clinical exacerbation in patients with AChR MG.

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

Main Objective: The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG).

Primary end point(s): Change in total influenza specific serum IgG titer in patients with AChR MG

Secondary Outcome(s)

Secondary end point(s): Clinical relevant change in clinical scores (2 points for MG-ADL, 3 points for the QMG and the MG composite). Approaches to look at the clinic:
1. The mean change of the test scores of the two groups (A+B vs. C+ D)
2. The number of patients who show a clinical relevant test on one of the tests en
compare this number of patients between the groups.
3. If a patient shows a clinical relevant change on a test, to look whether this is also
on the other tests en compare this number of patients between the two groups (A+B vs C+D).

- Change in autoimmune antibody titers against AChR.

- The effect of the pre-study medication (use of immunosuppressive medication) at the immunological response.

Timepoint(s) of evaluation of this end point: 4 weeks and 3 months

Secondary ID(s)

58746

Source(s) of Monetary Support

LUMC