Completed

NCT Number: NCT00731965

Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis

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.

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Key information

Conditions

Arthritis, Juvenile Rheumatoid Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Academic hospital Maastricht, Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all subtypes of JIA according to ILAR criteria
ages 4 to 9 (before the scheduled booster, normally administered at age 9 in the Netherlands)
5 healthy adults (aged 18 to 65y)

Exclusion criteria

use of Infliximab (Remicade, anti-Tumor Necrosis Factor (TNF) alpha therapy).
primary immunodeficiency
fever less than 48 hour prior to vaccination (vaccination will be postponed for 1 month)
evidence of viral or bacterial infection less than 48hours prior to vaccination (vaccination will be postponed for 1 month)
methylprednisolone pulse therapy less than 1 month prior to vaccination (vaccination will be postponed for 1 month)
transfusion of blood or blood products (e.g. intravenous immunoglobulins (IVIG)) in the 3 months prior to vaccination (vaccination will be postponed for 3 months)

Treatment and study plan

Measles, Mumps, Rubella vaccination

Biological

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 names: RVG 17654, BMR-NVI

Primary outcomes

JIA disease activity, defined by the core set criteria for JIA and number of flares

Time frame: baseline and after 3, 6,9,12 months

Secondary outcomes

Immunological reaction to MMR vaccination and regulatory mechanisms induced by MMR, measured by number and function of MMR-specific T cells and cytokine profiles

Time frame: baseline, 3 and 12 months

immunogenicity measuring antibody titers and T cell profileration to rubella virus

Sponsors and collaborators

Lead sponsor

N.M. Wulffraat

Other

Collaborators

Amsterdam UMC, location VUmc
Erasmus Medical Center
Maastricht University Medical Center
University Medical Center Groningen

Registry information

Official study title

Multicenter Randomized Clinical Trial in Patients With Juvenile Idiopathic Arthritis: Safety and Efficacy of Vaccination With Live Attenuated Measles, Mumps, Rubella Vaccine

Acronym: VAART

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Aug 11, 2008
Registry last updated: Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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