Crohn's Disease
Conditions
Keywords
Crohn's disease, Pneumococcal vaccination
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.
Interventions
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Sponsors
Wonju Severance Christian Hospital
Seoul National University Hospital
Asan Medical Center
Soonchunhyang University Hospital
Ewha Womans University
Kosin University Gospel Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
The Catholic University of Korea
Keimyung University Dongsan Medical Center
Korea University
Wonkwang University
Severance Hospital
Konkuk University Hospital
Kyunghee University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed