Condition category
Musculoskeletal Diseases
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
01/12/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms M.W. Heijstek

ORCID ID

Contact details

University Medical Centre Utrecht
Wilhelmina Children's Hospital
Utrecht
3584 EA
Netherlands
+31 (0)88 75 549 68
M.W.Heijstek@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00731965

Protocol/serial number

N/A

Study information

Scientific title

Acronym

VAART

Study hypothesis

The 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

Ethics approval received from the Centrale Commissie Mensgebonden Onderzoek (CCMO) and the Medical Ethics Committee of the participating centres for local feasibility on the 7th February 2008 (ref: NL 17376.000.07).

Study design

Multi-centre prospective randomised controlled open-label vaccination study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Juvenile Idiopathic Arthritis (JIA)

Intervention

Please note that as of 29/04/08 the anticipated start and end dates of this trial were updated to the above. The previous start and end dates were:
Previous anticipated start date: 01/12/2007
Previous anticipated end date: 01/12/2010

Included 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 type

Drug

Phase

Not Specified

Drug names

Measles, Mumps, Rubella vaccine

Primary outcome measures

Safety 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 measures

Secondary 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 trial start date

15/05/2008

Overall trial end date

15/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. All subtypes of JIA according to International League of Associations for Rheumatology (ILAR) criteria
2. Ages 4 to 8

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

280

Participant exclusion criteria

1. 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)

Recruitment start date

15/05/2008

Recruitment end date

15/05/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3584 EA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Utrecht (UMCU) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes