Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine - Full Text View

Purpose

The purpose of this study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) on immunosuppressive therapy with IBD patients on aminosalicylates and healthy historical controls.

Condition	Intervention
Inflammatory Bowel Disease (IBD) Immunosuppressed or Non-Immunosuppressed Influenza Vaccine Antibody Titers Seroprotective Titers	Other: blood draw

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Impact of Immunosuppression in Patients With Inflammatory Bowel Disease on Responsiveness to Influenza Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

seroprotection rate [ Time Frame: 3-8 weeks after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

vaccine-associated adverse events [ Time Frame: up to 8 weeks after vaccination ] [ Designated as safety issue: Yes ]
antibody titer levels [ Time Frame: 3-8 weeks after vaccination ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Blood for seroprotection rate and antibody titers

Enrollment:	146
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 IBD patients on immunosuppressive therapy	Other: blood draw drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)
2 IBD patients on non-immunosuppressive therapy (e.g., aminosalicylates, antibiotics) or on no medications	Other: blood draw drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)

Show Detailed Description

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients aged 5 years and older with documented inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis)

Criteria

Inclusion Criteria:

Crohn's disease, ulcerative colitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histologic criteria.
Age 5 years and older
Actively or previously followed by a gastroenterologist at Children's Hospital Boston
On non-immunosuppressants (aminosalicylates, antibiotics, or no medications) and/or immunosuppressants (steroids, immunomodulators, TNF-alpha inhibitors) for the past 30 days. Standard concomitant medications (e.g. antihistamines, acetaminophen) will be allowed.

Exclusion Criteria:

History of bleeding disorder that would make hematoma likely (eg hemophilia, von Willebrand's disease)
Received influenza vaccination during the current influenza season
Contraindications to the influenza vaccine (such as severe allergic reaction to prior influenza vaccine)
Fever within 48 hr prior to injection
Receipt of another vaccination within 2 days of influenza vaccine dose (and no other vaccines planned for 2 days after influenza vaccine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542776

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Thrasher Research Fund

Investigators

Principal Investigator:

Ying Lu, MD

Children's Hospital Boston

More Information

Publications:

Blumberg EA, Albano C, Pruett T, Isaacs R, Fitzpatrick J, Bergin J, Crump C, Hayden FG. The immunogenicity of influenza virus vaccine in solid organ transplant recipients. Clin Infect Dis. 1996 Feb;22(2):295-302.

Soesman NM, Rimmelzwaan GF, Nieuwkoop NJ, Beyer WE, Tilanus HW, Kemmeren MH, Metselaar HJ, de Man RA, Osterhaus AD. Efficacy of influenza vaccination in adult liver transplant recipients. J Med Virol. 2000 May;61(1):85-93.

Banic S, Koren S, Tomazic J, Vidmar L, Ihan A, Poljak M, Avsic-Zupanc A. Influenza vaccination of human immunodeficiency virus 1-infected patients receiving antiretroviral therapy. Acta Virol. 2001 Feb;45(1):39-44.

Matsuzaki A, Suminoe A, Koga Y, Kinukawa N, Kusuhara K, Hara T. Immune response after influenza vaccination in children with cancer. Pediatr Blood Cancer. 2005 Nov;45(6):831-7.

Cavdar C, Sayan M, Sifil A, Artuk C, Yilmaz N, Bahar H, Camsari T. The comparison of antibody response to influenza vaccination in continuous ambulatory peritoneal dialysis, hemodialysis and renal transplantation patients. Scand J Urol Nephrol. 2003;37(1):71-6.

Suga T, Niki H, Niikura M, Matsumoto Y, Nishimura T, Nakajima K, Miyazaki M, Endoh M, Nomoto Y, Sakai H. Influenza antibody titers after vaccination of chronic renal failure patients; before and during hemodialysis, or on continuous ambulatory peritoneal dialysis. Tokai J Exp Clin Med. 1990 May;15(2-3):245-51.

Holvast A, Huckriede A, Wilschut J, Horst G, De Vries JJ, Benne CA, Kallenberg CG, Bijl M. Safety and efficacy of influenza vaccination in systemic lupus erythematosus patients with quiescent disease. Ann Rheum Dis. 2006 Jul;65(7):913-8. Epub 2005 Dec 1.

Abu-Shakra M, Press J, Varsano N, Levy V, Mendelson E, Sukenik S, Buskila D. Specific antibody response after influenza immunization in systemic lupus erythematosus. J Rheumatol. 2002 Dec;29(12):2555-7.

Mamula P, Markowitz JE, Piccoli DA, Klimov A, Cohen L, Baldassano RN. Immune Response to Influenza Vaccine in Pediatric Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2007 Jul;5(7):851-856. Epub 2007 Jun 4.

Responsible Party:	Ying Lu, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00542776 History of Changes
Other Study ID Numbers:	07-09-0345
Study First Received:	October 9, 2007
Last Updated:	April 30, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

inflammatory bowel disease (IBD)
immunosuppressed or non-immunosuppressed
influenza vaccine

antibody titers
seroprotective titers
vaccine-associated adverse events

Additional relevant MeSH terms:

Inflammatory Bowel Diseases
Influenza, Human
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013