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| Name | Class |
|---|---|
| Wonju Severance Christian Hospital | OTHER |
| Seoul National University Hospital | OTHER |
| Asan Medical Center | OTHER |
| Soonchunhyang University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-TNF only | Experimental | Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only |
|
| Combined immunosuppression | Experimental | Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP]) |
|
| Immunomodulator only | Experimental | Crohn's disease, on an immunomodulator only |
|
| Non-immunosuppression | Experimental | Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23-valent polysaccharide pneumococcal vaccine | Drug | 23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serological response rates | 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of the vaccine | adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun-Soo Kim, MD, PhD | Yonsei University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University: Wonju Christian Hospital | Wŏnju | Gangwon-do | 220-701 | South Korea | ||
| Kosin University Gospel Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19755964 | Background | 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. | |
| 21674732 |
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| OTHER |
| Ewha Womans University | OTHER |
| Kosin University Gospel Hospital | OTHER |
| Chung-Ang University Hospital | 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 |
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|
| 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 | 130-702 | 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 |
| 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. |
| 21538710 | Background | 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. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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