Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
NCT ID: NCT01505855
Last Updated: 2014-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
197 participants
INTERVENTIONAL
2011-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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anti-TNF only
Crohn's disease, on an anti-TNF agent \[infliximab or adalimumab\] only
23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Combined immunosuppression
Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator \[azathioprine or 6-MP\])
23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Immunomodulator only
Crohn's disease, on an immunomodulator only
23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Non-immunosuppression
Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)
23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Interventions
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23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Wonju Severance Christian Hospital
OTHER
Seoul National University Hospital
OTHER
Asan Medical Center
OTHER
Soonchunhyang University Hospital
OTHER
Ewha Womans University
OTHER
Kosin University Gospel Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Inje University
OTHER
The Catholic University of Korea
OTHER
Keimyung University Dongsan Medical Center
OTHER
Korea University
OTHER
Wonkwang University
OTHER
Severance Hospital
OTHER
Konkuk University Hospital
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Chang Kyun Lee
Assistant Professor
Principal Investigators
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Hyun-Soo Kim, MD, PhD
Role: STUDY_CHAIR
Yonsei University
Locations
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Yonsei University: Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Soonchunhyang University
Cheonan, , South Korea
Keimyung University; Dongsan Hospital
Daegu, , South Korea
Wonkwang University
Iksan, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University
Seoul, , South Korea
Ewha Womans University
Seoul, , South Korea
Inje University; Seoul Paik Hospital
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Korea University; Ansan Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University; Severance Hospital
Seoul, , South Korea
The Catholic University of Korea; St. Vincent's Hospital
Suwon, , South Korea
Countries
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References
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Melmed GY, Agarwal N, Frenck RW, Ippoliti AF, Ibanez P, Papadakis KA, Simpson P, Barolet-Garcia C, Ward J, Targan SR, Vasiliauskas EA. Immunosuppression impairs response to pneumococcal polysaccharide vaccination in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 Jan;105(1):148-54. doi: 10.1038/ajg.2009.523. Epub 2009 Sep 15.
Fiorino G, Peyrin-Biroulet L, Naccarato P, Szabo H, Sociale OR, Vetrano S, Fries W, Montanelli A, Repici A, Malesci A, Danese S. Effects of immunosuppression on immune response to pneumococcal vaccine in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2012 Jun;18(6):1042-7. doi: 10.1002/ibd.21800. Epub 2011 Jun 14.
Wasan SK, Coukos JA, Farraye FA. Vaccinating the inflammatory bowel disease patient: deficiencies in gastroenterologists knowledge. Inflamm Bowel Dis. 2011 Dec;17(12):2536-40. doi: 10.1002/ibd.21667. Epub 2011 Apr 28.
Other Identifiers
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CD vaccination 1.2
Identifier Type: -
Identifier Source: org_study_id
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