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 |
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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
Scientific
University Medical Centre Utrecht
Wilhelmina Children's Hospital
Utrecht
3584 EA
Netherlands
Phone | +31 (0)88 75 549 68 |
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M.W.Heijstek@umcutrecht.nl |
Study information
Study design | Multi-centre prospective randomised controlled open-label vaccination study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | 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 |
Study acronym | VAART |
Study objectives | 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(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) studied | Juvenile Idiopathic Arthritis (JIA) |
Intervention | 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 | Biological/Vaccine |
Pharmaceutical study type(s) | |
Phase | |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | 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 study start date | 15/05/2008 |
Completion date | 15/05/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 4 Years |
Upper age limit | 8 Years |
Sex | Both |
Target number of participants | 280 |
Key inclusion criteria | 1. All subtypes of JIA according to International League of Associations for Rheumatology (ILAR) criteria 2. Ages 4 to 8 |
Key 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) |
Date of first enrolment | 15/05/2008 |
Date of final enrolment | 15/05/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3584 EA
Netherlands
3584 EA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
Hospital/treatment centre
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/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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