Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

Study Overview
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Brief Summary
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A growing number of patients with Crohn's disease are treated with immunosuppressive agents, such as anti-tumor necrosis factor blockers and immunomodulators. Several recent studies have indicated that immunosuppressive treatment may impair the immunological response to pneumococcal vaccination in patients with inflammatory bowel disease (Crohn's disease and Ulcerative colitis). One of weaknesses in the previous studies did not focus on specific disease, such as Crohn's disease. In addition, predictive factors affecting impaired response following pneumococcal vaccination have not clearly evaluated in patients with Crohn's disease. In this study, patients with Crohn's disease will be assessed for serological response to pneumococcal vaccination. Further, potential predictive factors that impact on vaccination outcomes and adverse events related to vaccination will be evaluated.

Official Title
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Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: 23-valent polysaccharide pneumococcal vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over the age of 18 Informed consent Patients who had a definitive diagnosis of Crohn's disease for more than 6 months (documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria) Exclusion Criteria: Hypersensitivity to any component of the pneumococcal vaccine Known allergy to pneumococcal vaccination Patients who treated with glucocorticoids (prednisolone > 20 mg/day equivalent for 2 weeks or more, and within 3 months of stopping Patients who inoculate another vaccine in the past 4 weeks Significant protein calorie malnutrition Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, infectious, neurologic or cerebral disease Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-TNF only<br>Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only | Drug: 23-valent polysaccharide pneumococcal vaccine<br>* 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection<br>* Other names: Pneumovax;|
| Experimental: Combined immunosuppression<br>Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP]) | Drug: 23-valent polysaccharide pneumococcal vaccine<br>* 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection<br>* Other names: Pneumovax;|
| Experimental: Immunomodulator only<br>Crohn's disease, on an immunomodulator only | Drug: 23-valent polysaccharide pneumococcal vaccine<br>* 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection<br>* Other names: Pneumovax;|
| Experimental: Non-immunosuppression<br>Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm) | Drug: 23-valent polysaccharide pneumococcal vaccine<br>* 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection<br>* Other names: Pneumovax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological response rates | Serological response rates, defined by number of patients showing adequate response to pneumococcal vaccination (at least a 2-fold increase in antipneumococcal antibodies in the serum compared with baseline) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment of the vaccine | adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, Pneumococcal vaccination