Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

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.

Conditions

• Crohn's Disease

Interventions

DRUG

23-valent polysaccharide pneumococcal vaccine

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

Sponsors & Collaborators

• Wonju Severance Christian Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• Ewha Womans University

  collaborator OTHER

• Kosin University Gospel Hospital

  collaborator OTHER

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  collaborator OTHER

• Inje University

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Korea University

  collaborator OTHER

• Wonkwang University

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Konkuk University Hospital

  collaborator OTHER

• Kyunghee University Medical Center

  lead OTHER

Principal Investigators

• Hyun-Soo Kim, MD, PhD · Yonsei University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• South Korea

Study Locations