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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

January 2, 2012
October 14, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
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)
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 antibododies in the serum compared with baseline)
Complete list of historical versions of study NCT01505855 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Efficacy Study of Pneumococcal Vaccination in Crohn's Disease
Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Crohn's Disease
Drug: 23-valent polysaccharide pneumococcal vaccine
23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
Other Name: Pneumovax
  • Experimental: anti-TNF only
    Crohn's disease, on an anti-TNF agent [infliximab or adalimumab] only
    Intervention: Drug: 23-valent polysaccharide pneumococcal vaccine
  • Experimental: Combined immunosuppression
    Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator [azathioprine or 6-MP])
    Intervention: Drug: 23-valent polysaccharide pneumococcal vaccine
  • Experimental: Immunomodulator only
    Crohn's disease, on an immunomodulator only
    Intervention: Drug: 23-valent polysaccharide pneumococcal vaccine
  • Experimental: Non-immunosuppression
    Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)
    Intervention: Drug: 23-valent polysaccharide pneumococcal vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01505855
CD vaccination 1.2
Yes
Chang Kyun Lee, Kyunghee University Medical Center
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
Study Chair: Hyun-Soo Kim, MD, PhD Yonsei University
Kyunghee University Medical Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP