Efficacy Study of Pneumococcal Vaccination in Crohn's Disease

NCT01505855 | Completed Phase 4 DMC

• 1 other identifier: CD vaccination 1.2
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Crohn's disease; Pneumococcal vaccination

Outcome Measures

Primary Outcomes (1)

• Serological response rates

  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)

  4 weeks

Secondary Outcomes (1)

• Safety assessment of the vaccine

  8 weeks

Study Arms (4)

anti-TNF only

EXPERIMENTAL

Crohn's disease, on an anti-TNF agent \[infliximab or adalimumab\] only

Drug: 23-valent polysaccharide pneumococcal vaccine

Combined immunosuppression

EXPERIMENTAL

Crohn's disease, on combined immunosuppression (both anti-TNF agent and immunomodulator \[azathioprine or 6-MP\])

Drug: 23-valent polysaccharide pneumococcal vaccine

Immunomodulator only

EXPERIMENTAL

Crohn's disease, on an immunomodulator only

Drug: 23-valent polysaccharide pneumococcal vaccine

Non-immunosuppression

EXPERIMENTAL

Crohn's disease, not on immunosuppressive medications (5-ASA only: control arm)

Drug: 23-valent polysaccharide pneumococcal vaccine

Interventions

23-valent polysaccharide pneumococcal vaccine DRUG

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

Also known as: Pneumovax

Combined immunosuppression; Immunomodulator only; Non-immunosuppression; anti-TNF only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• Wonju Severance Christian Hospital: collaborator
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Soonchunhyang University Hospital: collaborator
• Ewha Womans University: collaborator
• Kosin University Gospel Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Inje University: collaborator
• The Catholic University of Korea: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Korea University: collaborator
• Wonkwang University: collaborator
• Severance Hospital: collaborator
• Konkuk University Hospital: collaborator

Study Sites (15)

Yonsei University: Wonju Christian Hospital

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Soonchunhyang University

Cheonan, South Korea

Location

Keimyung University; Dongsan Hospital

Daegu, South Korea

Location

Wonkwang University

Iksan, South Korea

Location

Kyung Hee University Hospital

Seoul, 130-702, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University

Seoul, South Korea

Location

Ewha Womans University

Seoul, South Korea

Location

Inje University; Seoul Paik Hospital

Seoul, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Korea University; Ansan Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University; Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea; St. Vincent's Hospital

Suwon, South Korea

Location

Related Publications (3)

• Melmed GY, Agarwal N, Frenck RW, Ippoliti AF, Ibanez P, Papadakis KA, Simpson P, Barolet-Garcia C, Ward J, Targan SR, Vasiliauskas EA. Immunosuppression impairs response to pneumococcal polysaccharide vaccination in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 Jan;105(1):148-54. doi: 10.1038/ajg.2009.523. Epub 2009 Sep 15.

  PMID: 19755964 BACKGROUND

• Fiorino G, Peyrin-Biroulet L, Naccarato P, Szabo H, Sociale OR, Vetrano S, Fries W, Montanelli A, Repici A, Malesci A, Danese S. Effects of immunosuppression on immune response to pneumococcal vaccine in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2012 Jun;18(6):1042-7. doi: 10.1002/ibd.21800. Epub 2011 Jun 14.

  PMID: 21674732 BACKGROUND

• Wasan SK, Coukos JA, Farraye FA. Vaccinating the inflammatory bowel disease patient: deficiencies in gastroenterologists knowledge. Inflamm Bowel Dis. 2011 Dec;17(12):2536-40. doi: 10.1002/ibd.21667. Epub 2011 Apr 28.

  PMID: 21538710 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hyun-Soo Kim, MD, PhD

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 9, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

KR (15)