Clinical trial NCT01505855: Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
Official title: Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn's disease
Pneumococcal vaccination
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Wonju Severance Christian Hospital
name: Seoul National University Hospital
name: Asan Medical Center
name: Soonchunhyang University Hospital
name: Ewha Womans University
name: Kosin University Gospel Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Inje University
name: The Catholic University of Korea
name: Keimyung University Dongsan Medical Center
name: Korea University
name: Wonkwang University
name: Severance Hospital
name: Konkuk University Hospital
First posted: 2012-01-09
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serological response rates
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety assessment of the vaccine
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University: Wonju Christian Hospital
state: Kangwon-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University
city: Daegu
country: Korea, Republic of
facility: Keimyung University; Dongsan Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University
city: Seoul
country: Korea, Republic of
facility: Inje University; Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University; Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University; Severance Hospital
city: Seul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea; St. Vincent's Hospital
Study officials:
affiliation: Yonsei University
name: Hyun-Soo Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.