Skip to main content
OpenTrials
Completed

NCT Number: NCT01505855

Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University: Wonju Christian Hospital, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

23-valent polysaccharide pneumococcal vaccine

Drug

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

Other names: Pneumovax

Primary outcomes

  1. Serological response rates

    Time frame: 4 weeks

    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 outcomes

  1. Safety assessment of the vaccine

    Time frame: 8 weeks

    adverse events related to vaccine administration, including worsening of Crohn's disease activity by changes in Harvey-Bradshaw index (HBI) and inflammatory markers

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2012
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.