Arthritis, Juvenile Rheumatoid Clinical Trial
Official title:
Multicenter Randomized Clinical Trial in Patients With Juvenile Idiopathic Arthritis: Safety and Efficacy of Vaccination With Live Attenuated Measles, Mumps, Rubella Vaccine
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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