VAccination in ARThritis (VAART-onderzoek) - multicentre randomised clinical trial in patients with juvenile idiopathic arthritis: safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine

ISRCTN ISRCTN12271664
DOI https://doi.org/10.1186/ISRCTN12271664
ClinicalTrials.gov number NCT00731965
Secondary identifying numbers N/A
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
14/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms M.W. Heijstek
Scientific

University Medical Centre Utrecht
Wilhelmina Children's Hospital
Utrecht
3584 EA
Netherlands

Phone +31 (0)88 75 549 68
Email M.W.Heijstek@umcutrecht.nl

Study information

Study designMulti-centre prospective randomised controlled open-label vaccination study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleVAccination in ARThritis (VAART-onderzoek) - multicentre randomised clinical trial in patients with juvenile idiopathic arthritis: safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
Study acronymVAART
Study objectivesThe primary objective of the study is to study the safety of Measles, Mumps, Rubella (MMR) booster vaccination in Juvenile Idiopathic Arthritis (JIA) patients by measuring JIA disease activity and the occurrence of measles, mumps or rubella infection.

The next primary objective is to evaluate the efficacy of the MMR booster vaccination in JIA patients by measuring protective immunity responses (specific anti measles, rubella, mumps antibodies by Enzyme-Linked Immunosorbent Assay [ELISA]) and functional antibody assays (measles neutralising antibodies) before and after MMR vaccination.

The secondary aim of the vaccination study is to analyse the influence on immune regulatory mechanisms capable of inducing JIA disease remission.
Ethics approval(s)Centrale Commissie Mensgebonden Onderzoek (CCMO) and the Medical Ethics Committee of the participating centres for local feasibility, 07/02/2008, ref: NL 17376.000.07
Health condition(s) or problem(s) studiedJuvenile Idiopathic Arthritis (JIA)
InterventionIncluded patients will be randomised for one extra MMR booster vaccination (at age 4 to 8) or no additional vaccination (controls). Placebo vaccines will not be used in the control group.

N.B. In the Netherlands all children receive MMR booster vaccination at 9 years of age. Patients in both groups will also receive their usual MMR booster vaccine at age 9 according to the National Vaccination Program.
Intervention typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureSafety of MMR vaccination, according to:
1. JIA disease activity (defined by internationally validated core set criteria, number of disease flares in the 12 months after MMR vaccination and medication use), measured at baseline, and 3, 6 and 12 months after vaccination
2. Efficacy of MMR booster, defined by specific antibodies against measles, mumps and rubella, measured at baseline and 3 and 12 months after vaccination
Secondary outcome measuresSecondary outcome measures are:
1. Number of Tregs, that are capable to suppress proliferation in vitro
2. Presence of anti-inflammatory cytokine profiles following MMR booster
3. Number and function of MMR-specific T cells

These are measured at baseline and three months after vaccination.
Overall study start date15/05/2008
Completion date15/05/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit8 Years
SexBoth
Target number of participants280
Key inclusion criteria1. All subtypes of JIA according to International League of Associations for Rheumatology (ILAR) criteria
2. Ages 4 to 8
Key exclusion criteria1. Use of Infliximab (Remicade, anti-Tumour Necrotising Factor [anti-TNF] alpha therapy)
2. Participation in another (drug) trial
3. Primary immunodeficiency
4. Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for one month)
5. Evidence of viral or bacterial infection less than 48 hours prior to vaccination (here the moment of vaccination will be postponed for one month)
6. Methylprednisolone pulse therapy less than one month prior to vaccination (in these cases, the moment of vaccination will be postponed for one month)

Please note that, as of 11/09/2008, the following exclusion criterion has been removed:
Use of Anakinra (Kineret, human interleukine-1-receptor antagonist)
Date of first enrolment15/05/2008
Date of final enrolment15/05/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht
Utrecht
3584 EA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre

Wilhelmina Children's Hospital (WKZ)
PO Box 85090
KC.03.063.0
Utrecht
3508 AB
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "ROR" https://ror.org/04pp8hn57

Funders

Funder type

Hospital/treatment centre

University Medical Centre Utrecht (UMCU) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 19/06/2013 14/02/2019 Yes No

Editorial Notes

14/02/2019: Publication reference added.
29/04/2008: The overall trial start and end dates of this trial were updated. The previous start and end dates were:
Previous overall trial start date: 01/12/2007
Previous overall trial end date: 01/12/2010