Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000360

Trial Description

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Title

Prospective, randomised, doubleblind, placebo controlled trial on changes in acetylcholine receptor antibody titers in autoimmune myasthenia gravis after influenza vaccination
EudraCT-Nr. 2006-004374-27

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Trial Acronym

ProPATIent

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URL of the Trial

http://n. a.

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Brief Summary in Lay Language

It is unknown, wether vaccination in gerneral and especially anti-Influenza vaccination is relevant for the course of myasthenia gravis. In this stud we adress the question, whether myasthenia gravis is a balk for anti-Influenza vaccination. From german legal authorities all healthy humans with age > 60 years (and in special cases alsoger people) were recommended to be vaccinated. The scientific literature does not yet provide evidence for a clear benefit of vaccination in autoimmunity. However, there are hints for a possible causal relationship between vaccination and the onset of immune mediated diseases, like muscle pareses (Guillain-Barre syndrome), inflammation of the brain and spinal cord or inflammation of the vessels. In the ProPATIent-trial the changes in the titer of the Acetylcholinereceptor antibody after vaccination will be systematically analysed.

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Brief Summary in Scientific Language

Myasthenia gravis (MG) is an autoimmune disease with T-helper cell dependent acetylcholine receptor antibodies, leading to muscle weakness with recovery at rest. Anti-influenza vaccination leads to a T-cell mediated anti-Influenza antibody response against seasonal influenza viruses. It is unclear whether boostering by vaccination may lead to a clinical worsening or changes in the AChR-antibody titer.
Here we present a prospective, randomized, double-blind, placebo-controlled trial to detect changes in the AChR-antibody titers in a 5 months follow-up after vaccination. Secondary endpoints to detect clincially relevant changes are Besinger-score and changes in medication dosage (pyridostigmine).

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Organizational Data

  •   DRKS00000360
  •   2010/03/11
  •   [---]*
  •   yes
  •   Approved
  •   148/06, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  •   2006-004374-27 
  •   293/04 
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Health Condition or Problem studied

  •   G70.0 -  Myasthenia gravis
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Interventions/Observational Groups

  •   Mutagrip (vaccine)
    intramuscular injection in standard manner (deltoid muscle)
  •   NaCl 0,9% (placebo)
    intramuscular injection in standard manner (deltoid muscle)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Other
  •   Parallel
  •   II-III
  •   [---]*
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Primary Outcome

relative changes in % of the AChR-ab titer within three months after anti-Influenza vaccination

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Secondary Outcome

vaccination success, changes in pyridostigmine and/or immunosuppresants dosage, modified Besinger-/MGFA score to quantify weakness

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2006/11/16
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

written informed consent
age at least 18 years
age of 80 years maximum
diagnosis of myasthenia gravis according the guideline of the German Neurological Society
positve anti-AChR abs
clinically stable for at least 4 months

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Exclusion Criteria

any vaccination within 9 months prior to study entry
history of severe heart disease
cardiac arrythmia
History of cancer
acute infection at screening or Visit 1
allergy against chicken protein
History of severe vaccination reaction

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Addresses

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    • Philipps-Universität Marburg Koordinierungszentrum für Klinische Studien (KKS)
    • Ms.  Carmen  Schade-Brittinger 
    • Karl-von-Frisch Str. 4
    • 35043  Marburg
    • Germany
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    • Philipps-Universität Marburg Klinik für Neurologie
    • Mr.  Dr.  Björn  Tackenberg 
    • Rudolf-Bultmann-Str. 8
    • 35039  Marburg
    • Germany
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    • Philipps-Universität Marburg Klinik für Neurologie
    • Ms.  Babette  von Hagen 
    • Rudolf-Bultmann-Str. 8
    • 35039  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Förderverein Neurologi für Forschung, Ausbildung und Therapie, e. V.
    • Mr.  Prof. Dr.  Felix  Rosenow 
    • Rudolf-Bultmann- Str. 8
    • 35039  Marburg
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.