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Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

This study is currently recruiting participants.
Verified January 2013 by Kyunghee University Medical Center
Sponsor:
Collaborators:
Yonsei University
Seoul National University Hospital
Asan Medical Center
Soonchunhyang University Hospital
Ewha Womans University
Kosin University Gospel Hospital
Chung-Ang University Hospital
Inje University
The Catholic University of Korea
Keimyung University Dongsan Medical Center
Korea University
Wonkwang University
Severance Hospital
Konkuk University Hospital
Information provided by (Responsible Party):
Chang Kyun Lee, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01505855
First received: January 2, 2012
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Drug: 23-valent polysaccharide pneumococcal vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Serological response rates [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers


Estimated Enrollment: 172
Study Start Date: December 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anti-TNF only
Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only
 Drug: 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Name: Pneumovax
Experimental: Combined immunosuppression
Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP])
 Drug: 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Name: Pneumovax
Experimental: Immunomodulator only
Crohn's disease, on an immunomodulator only
 Drug: 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Name: Pneumovax
Experimental: Non-immunosuppression
Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)
 Drug: 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Name: Pneumovax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505855

Contacts
Contact: Chang Kyun Lee, MD, PhD 82-2-958-8258 cklee92@paran.com
Contact: Hyo Jong Kim, MD, PhD 82-2-958-8199 hjkim@khmc.or.kr

Locations
Korea, Republic of
Yonsei University: Wonju Christian Hospital Recruiting
Wonju, Kangwon-do, Korea, Republic of, 220-701
Contact: Hyun-Soo Kim, MD, PhD     82-33-741-1229     hyskim@yonsei.ac.kr    
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of
Contact: Won Moon, MD, PhD         moonone70@hanmail.net    
Soonchunhyang University Recruiting
Cheonan, Korea, Republic of
Contact: Suck-Ho Lee, MD, PhD     82-10-8917-3830     ygun99@hanmail.net    
Keimyung University; Dongsan Hospital Recruiting
Daegu, Korea, Republic of
Contact: Eun Soo Kim, MD, PhD         dandy813@dsmc.or.kr    
Wonkwang University Recruiting
Iksan, Korea, Republic of
Contact: Geom Seog Seo, MD, PhD         medsgs@wonkwang.ac.kr    
Yonsei University; Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sung-Pil Hong, MD, PhD     82-10-8940-5775     sphong@yuhs.ac    
Chung-Ang University Recruiting
Seoul, Korea, Republic of
Contact: Chang Hwan Choi, MD, PhD         gicch@cau.ac.kr    
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Byong Duk Ye, MD, PhD     82-2-3010-3299     bdyemd@gmail.com    
Ewha Womans University Recruiting
Seoul, Korea, Republic of
Contact: Sung-Eun Kim, MD, PhD         kimse@ewha.ac.kr    
Inje University; Seoul Paik Hospital Recruiting
Seoul, Korea, Republic of
Contact: You Sun Kim, MD, PhD         yousunk69@korea.com    
Korea University; Ansan Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ja-Seol Koo, MD, PhD         jskoo@korea.ac.kr    
Konkuk University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sung Noh Hong, MD, PhD         20070253@kuh.ac.kr    
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 130-702
Contact: Chang Kyun Lee, MD, PhD     82-2-958-8258     cklee92@paran.com    
Contact: Eun-Jung Kim, RN         realanais@naver.com    
Seoul National University Hospital Recruiting
Seul, Korea, Republic of
Contact: Jong-Pil Im, MD, PhD     82-10-8635-6997     jp-im@hanmail.net    
The Catholic University of Korea; St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of
Contact: Kang Moon Lee, MD, PhD         drmaloman@catholic.ac.kr    
Sponsors and Collaborators
Kyunghee University Medical Center
Yonsei University
Seoul National University Hospital
Asan Medical Center
Soonchunhyang University Hospital
Ewha Womans University
Kosin University Gospel Hospital
Chung-Ang University Hospital
Inje University
The Catholic University of Korea
Keimyung University Dongsan Medical Center
Korea University
Wonkwang University
Severance Hospital
Konkuk University Hospital
Investigators
Study Chair: Hyun-Soo Kim, MD, PhD Yonsei University
  More Information

Publications:

Responsible Party: Chang Kyun Lee, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01505855     History of Changes
Other Study ID Numbers: CD vaccination 1.2
Study First Received: January 2, 2012
Last Updated: January 15, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
Crohn's disease
Pneumococcal vaccination

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013