Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

Kyung Hee University

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: 23-valent polysaccharide pneumococcal vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01505855

CD vaccination 1.2

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 4 patient groups

anti-TNF only

Experimental group

Description:

Crohn's disease, on an anti-TNF agent \[infliximab or adalimumab\] only

Treatment:

Drug: 23-valent polysaccharide pneumococcal vaccine

Combined immunosuppression

Experimental group

Description:

Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator \[azathioprine or 6-MP\])

Treatment:

Drug: 23-valent polysaccharide pneumococcal vaccine

Immunomodulator only

Experimental group

Description:

Crohn's disease, on an immunomodulator only

Treatment:

Drug: 23-valent polysaccharide pneumococcal vaccine

Non-immunosuppression

Experimental group

Description:

Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)

Treatment:

Drug: 23-valent polysaccharide pneumococcal vaccine