Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Measles; Rubella; Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      Background:

      The safety of vaccination in patients with autoimmune diseases using immune suppressive
      therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients
      showed no increase in disease activity after immunisation with dead vaccines. The safety of
      the live attenuated Measles, Mumps, Rubella (MMR) vaccination was assessed retrospectively in
      JIA patients and no increase in disease activity was found. However, this must be
      prospectively confirmed. In addition, it is unknown whether vaccination is effective, since
      the immune response to vaccination may be diminished due to immunosuppressive therapy for the
      underlying disease. Finally, the influence of MMR vaccination on the immune system of JIA
      patients has not been studied. Among others, regulatory T-cells (Tregs) should control the
      immune response and prevent destructive autoimmune responses after environmental triggers
      such as vaccination.

      Objective:

      The aim of the present study is to investigate the safety and efficacy of the MMR booster
      vaccination and its influence on immune regulatory mechanisms in children with Juvenile
      Idiopathic Arthritis.

      Method:

      JIA patients aged 4 to 8 years and treated by the pediatric rheumatology units from various
      University Medical Centers in the Netherlands, are asked to participate in a prospective
      study. In the Netherlands, measles-mumps-rubella (MMR) vaccination is included in the
      National Vaccination Program and is normally administered at age 9. Included patients will be
      randomised for early vaccination (age group 4 to 8yr at entry of the study) or at age 9 as is
      routinely done according to the National Vaccination Program. Prior to and after vaccination
      the investigators will assess disease activity and collect blood.

      Outcome:

      During a 12 month follow-up period the investigators will register disease activity and
      side-effects at different moments in time to determine safety of vaccination. The efficacy of
      the vaccine will be studied according to antibody levels and function against measles, mumps
      and rubella in the blood. Tregs will be isolated and their functionality will be determined
      using the blood cells collected during follow-up. This enables us to study the role influence
      of vaccination on regulatory mechanisms in our immune system.
    


Intervention name(s): Measles, Mumps, Rubella vaccination
Intervention type(s): Biological
Intervention description(s): Dosage: 1 dose MMR vaccine, containing 5000 p.f.u. (plaque forming unit) life attenuated mumps virus (Jeryl-Lynn-strain), 1000 p.f.u. life attenuated measles virus (Moraten-strain) and 1000 p.f.u. life attenuated rubella virus (Wistar RA 27/3-strain) + 0.5 ml solution fluid Dosage form: subcutaneously frequency: once
Other intervention name(s): RVG 17654, BMR-NVI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Arthritis, Juvenile Rheumatoid; Measles-Mumps-Rubella Vaccine; Serology; Lymphocytes