1. IBD patients treated with immunosuppressive agents have a diminished anti-pneumococcal antibody response to pneumococcal vaccination. 2. (A) Use of a TNF-alpha inhibitor is associated with a lower antibody response after pneumococcal…
ID
Bron
Verkorte titel
Aandoening
inflammatory bowel disease (inflammatoire darmziekte)
immunosuppressive agents (immunosuppressiva)
pneumococcal vaccination (pneumokokkenvaccinatie)
vaccine immunogenicity (vaccin immunogeniciteit)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The ratio of the anti-pneumococcal antibodies measured before and four to six weeks after pneumococcal vaccination (T=week0 – PCV13 and T1= 8weeks – PPV23). An adequate response is considered as a 2-fold increase in anti-pneumococcal antibodies.
Achtergrond van het onderzoek
This study aims to study the immunogenicity of pneumococcal vaccination with prevenar-13 and two months later, pneumovax-23 in IBD patients on immunosuppressive treatment. To evaluate immunogenicity antibody titers are measured at inclusion and 4-8 weeks after administration of pneumovax-23. Patiets are divided in different groups of immunosuppressive treatment to assess how different immunosuppressives affect immunogenicity of pneumococcal vaccination. Furhtermore, patients will be included who start anti-TNF treatment in the period before, between or after the 2 pneumococcal vaccines, in order to assess whether the starting time of immunosuppressives related to the vaccination schedule further affects immunogenicity. We plan to include 188 participants.
Doel van het onderzoek
1. IBD patients treated with immunosuppressive agents have a diminished anti-pneumococcal antibody response to pneumococcal vaccination.
2. (A) Use of a TNF-alpha inhibitor is associated with a lower antibody response after pneumococcal vaccination than after use of DMARDs and/or corticosteroids. Use of either high-dose monotherapy with a TNF-alpha inhibitor; and (B) use of standard dose TNF-alpha inhibitor plus additional immunosuppressive drugs are associated with an even lower antibody response after pneumococcal vaccination.
3. A longer time-interval between pneumococcal vaccination and treatment initiation with TNF-alpha inhibitors is associated with an enhanced antibody response.
Onderzoeksopzet
Not applicable
Onderzoeksproduct en/of interventie
Pneumococcal vaccination with Prevenar-13 and Pneumovax-23, which is recommended for patients with auto-immune disease.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age > 18 years old
On treatment with an immunosuppressive agent or planned treatment start with a TNF-alpha inhibitor within 3 months after recruitment
Indication for pneumococcal vaccination (PCV13 plus PPV23)
Able and willing to consent
Control group: IBD patients not treated with immunosuppressives
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Diagnosis of a primary immune deficiency disorder
Age < 18 years
Control group: treatment with immunosuppressive drugs
Not being able to or not willing to consent
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6168 |
NTR-old | NTR6315 |
CCMO | NL58768.018.16 |
OMON | NL-OMON45696 |