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Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
23-valent polysaccharide pneumococcal vaccine
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Crohn's disease, Pneumococcal vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University: Wonju Christian Hospital
  • Kosin University Gospel Hospital
  • Soonchunhyang University
  • Keimyung University; Dongsan Hospital
  • Wonkwang University
  • Kyung Hee University Hospital
  • Asan Medical Center
  • Chung-Ang University
  • Ewha Womans University
  • Inje University; Seoul Paik Hospital
  • Konkuk University Hospital
  • Korea University; Ansan Hospital
  • Yonsei University; Severance Hospital
  • Seoul National University Hospital
  • The Catholic University of Korea; St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

anti-TNF only

Combined immunosuppression

Immunomodulator only

Non-immunosuppression

Arm Description

Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only

Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP])

Crohn's disease, on an immunomodulator only

Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2012
Last Updated
October 14, 2014
Sponsor
Kyunghee University Medical Center
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01505855
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Pneumococcal vaccination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anti-TNF only
Arm Type
Experimental
Arm Description
Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only
Arm Title
Combined immunosuppression
Arm Type
Experimental
Arm Description
Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP])
Arm Title
Immunomodulator only
Arm Type
Experimental
Arm Description
Crohn's disease, on an immunomodulator only
Arm Title
Non-immunosuppression
Arm Type
Experimental
Arm Description
Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)
Intervention Type
Drug
Intervention Name(s)
23-valent polysaccharide pneumococcal vaccine
Other Intervention Name(s)
Pneumovax
Intervention Description
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Primary Outcome Measure Information:
Title
Serological response rates
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety assessment of the vaccine
Description
adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Soo Kim, MD, PhD
Organizational Affiliation
Yonsei University
Official's Role
Study Chair
Facility Information:
Facility Name
Yonsei University: Wonju Christian Hospital
City
Wonju
State/Province
Kangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Soonchunhyang University
City
Cheonan
Country
Korea, Republic of
Facility Name
Keimyung University; Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Wonkwang University
City
Iksan
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University; Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University; Ansan Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University; Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea; St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19755964
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.
Results Reference
background
PubMed Identifier
21674732
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.
Results Reference
background
PubMed Identifier
21538710
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.
Results Reference
background

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Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

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