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ID
Source
Brief title
Health condition
inflammatory bowel disease (inflammatoire darmziekte)
immunosuppressive agents (immunosuppressiva)
pneumococcal vaccination (pneumokokkenvaccinatie)
vaccine immunogenicity (vaccin immunogeniciteit)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The difference in response rates to pneumococcal vaccination between the control and intervention groups.
Background summary
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.
Study objective
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.
Study design
Not applicable
Intervention
Pneumococcal vaccination with Prevenar-13 and Pneumovax-23, which is recommended for patients with auto-immune disease.
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6168 |
| NTR-old | NTR6315 |
| CCMO | NL58768.018.16 |
| OMON | NL-OMON45696 |