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

Recruiting
Conditions
inflammatory bowel disease (inflammatoire darmziekte)immunosuppressive agents (immunosuppressiva)pneumococcal vaccination (pneumokokkenvaccinatie)vaccine immunogenicity (vaccin immunogeniciteit)
Registration Number
NL-OMON29135
Lead Sponsor
Academic Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
188
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

Exclusion Criteria

Diagnosis of a primary immune deficiency disorder

Age < 18 years

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Measures
NameTimeMethod
The difference in response rates to pneumococcal vaccination between the control and intervention groups.
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