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De antistof respons na pneumokokkenvaccinatie bij IBD-patiënten die behandeld worden met immunosuppressiva – de PNEUMOREACT studie


- candidate number27037
- NTR NumberNTR6315
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-apr-2017
- Secondary IDsNL58768.018.16 METC 2016_247
- Public TitleDe antistof respons na pneumokokkenvaccinatie bij IBD-patiënten die behandeld worden met immunosuppressiva – de PNEUMOREACT studie
- Scientific TitleAntibody response to pneumococcal vaccination in patients with inflammatory bowel disease patients treated with immunosuppressive agents - the PNEUMOREACT study
- ACRONYMPNEUMOREACT
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedIBD, Pneumococcal vaccination, Immunosuppression
- Inclusion criteriaAge > 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 criteriaDiagnosis of a primary immune deficiency disorder
Age < 18 years
Control group: treatment with immunosuppressive drugs
Not being able to or not willing to consent
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 6-dec-2016
- planned closingdate31-jan-2018
- Target number of participants188
- InterventionsPneumococcal vaccination with Prevenar-13 and Pneumovax-23, which is recommended for patients with auto-immune disease.
- Primary outcomeThe 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 outcomeThe difference in response rates to pneumococcal vaccination between the control and intervention groups.
- Timepoints Not applicable
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marielle Van Aalst
- CONTACT for SCIENTIFIC QUERIES M.P. Grobusch
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD4-apr-2017 - 24-mei-2017


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