Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

This study has been completed.
Sponsor:
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 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: October 14, 2014
Last verified: October 2014
  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:


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


Enrollment: 197
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505855

Locations
Korea, Republic of
Yonsei University: Wonju Christian Hospital
Wonju, Kangwon-do, Korea, Republic of, 220-701
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
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-702
Yonsei University; Severance Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Ewha Womans University
Seoul, Korea, Republic of
Inje University; Seoul Paik Hospital
Seoul, Korea, Republic of
Korea University; Ansan Hospital
Seoul, Korea, Republic of
Konkuk University Hospital
Seoul, Korea, Republic of
Chung-Ang University
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
Sponsors and Collaborators
Kyunghee University Medical Center
Wonju Severance Christian Hospital
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: October 14, 2014
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 October 16, 2014