Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine

NCT00542776 | Completed DMC

• 1 other identifier: 07-09-0345
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD); Immunosuppressed or Non-Immunosuppressed; Influenza Vaccine; Antibody Titers; Seroprotective Titers

Keywords

inflammatory bowel disease (IBD); immunosuppressed or non-immunosuppressed; influenza vaccine; antibody titers; seroprotective titers; vaccine-associated adverse events

Outcome Measures

Primary Outcomes (1)

• seroprotection rate

  3-8 weeks after vaccination

Secondary Outcomes (2)

• vaccine-associated adverse events

  up to 8 weeks after vaccination

• antibody titer levels

  3-8 weeks after vaccination

Study Arms (2)

1

IBD patients on immunosuppressive therapy

Other: blood draw

2

IBD patients on non-immunosuppressive therapy (e.g., aminosalicylates, antibiotics) or on no medications

Other: blood draw

Interventions

blood draw OTHER

drawing blood for seroprotection and antibody titers to the 3 strains of influenza on Day 1 and Month 1 (3-8 weeks)

1; 2

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (9)

• 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. doi: 10.1093/clinids/22.2.295.

  PMID: 8838186 BACKGROUND

• 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.

  PMID: 10745238 BACKGROUND

• 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.

  PMID: 11394576 BACKGROUND

• 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. doi: 10.1002/pbc.20470.

  PMID: 16007602 BACKGROUND

• 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. doi: 10.1080/00365590310008749.

  PMID: 12745749 BACKGROUND

• 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.

  PMID: 2130531 BACKGROUND

• 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. doi: 10.1136/ard.2005.043943. Epub 2005 Dec 1.

  PMID: 16322083 BACKGROUND

• 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.

  PMID: 12465151 BACKGROUND

• 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):851-6. doi: 10.1016/j.cgh.2007.02.035. Epub 2007 Jun 4.

  PMID: 17544875 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for seroprotection rate and antibody titers

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Influenza, Human

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ying Lu, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 11, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 1, 2008

Record last verified: 2007-12

Locations

US (1)