Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505855
• Other study ID #: CD vaccination 1.2
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2012
• Last updated: October 14, 2014
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Soonchunhyang University	Cheonan
Korea, Republic of	Keimyung University; Dongsan Hospital	Daegu
Korea, Republic of	Wonkwang University	Iksan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University	Seoul
Korea, Republic of	Ewha Womans University	Seoul
Korea, Republic of	Inje University; Seoul Paik Hospital	Seoul
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Korea University; Ansan Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Yonsei University; Severance Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seul
Korea, Republic of	The Catholic University of Korea; St. Vincent's Hospital	Suwon
Korea, Republic of	Yonsei University: Wonju Christian Hospital	Wonju	Kangwon-do

Sponsors (15)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Asan Medical Center, Chung-Ang University Hospital, Ewha Womans University, Inje University, Keimyung University Dongsan Medical Center, Konkuk University Hospital, Korea University, Kosin University Gospel Hospital, Seoul National University Hospital, Severance Hospital, Soonchunhyang University Hospital, The Catholic University of Korea, Wonju Severance Christian Hospital, Wonkwang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Fiorino G, Peyrin-Biroulet L, Naccarato P, Szabò 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes