NCT01505855

Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	23-valent polysaccharide pneumococcal vaccine	23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-01-09
• Last updated: 2014-10-16

Locations

15 sites across 1 country: South Korea