Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- 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)
- 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)
Seoul National University Hospital
🇰🇷Seul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University
🇰🇷Cheonan, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University; Ansan Hospital
🇰🇷Seoul, Korea, Republic of
Keimyung University; Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Chung-Ang University
🇰🇷Seoul, Korea, Republic of
Inje University; Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea; St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University: Wonju Christian Hospital
🇰🇷Wonju, Kangwon-do, Korea, Republic of
Wonkwang University
🇰🇷Iksan, Korea, Republic of
Yonsei University; Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University
🇰🇷Seoul, Korea, Republic of