Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: 23-valent polysaccharide pneumococcal vaccine

• Registration Number: NCT01505855
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-TNF only	23-valent polysaccharide pneumococcal vaccine	Crohn's disease, on an anti-TNF agent \[infliximab or adalimumab\] only
Combined immunosuppression	23-valent polysaccharide pneumococcal vaccine	Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator \[azathioprine or 6-MP\])
Immunomodulator only	23-valent polysaccharide pneumococcal vaccine	Crohn's disease, on an immunomodulator only
Non-immunosuppression	23-valent polysaccharide pneumococcal vaccine	Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)

Primary Outcome Measures

Name	Time	Method
Serological response rates	4 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Yonsei University: Wonju Christian Hospital; 🇰🇷 Wonju, Kangwon-do, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Soonchunhyang University; 🇰🇷 Cheonan, Korea, Republic of

Keimyung University; Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Wonkwang University; 🇰🇷 Iksan, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University; 🇰🇷 Seoul, Korea, Republic of

Inje University; Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

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