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Flu Vaccine Response in Patients on Biologic Therapies

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ClinicalTrials.gov Identifier: NCT03277703
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Christy Beneri, Stony Brook University

Brief Summary:
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.

Condition or disease Intervention/treatment Phase
Rheumatologic Disorder Inflammatory Bowel Diseases Immune Complex Diseases Biological: Influenza vaccine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1 - Booster
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2.
Biological: Influenza vaccine

The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.

Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population


Active Comparator: Group 2 - Standard
Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2.
Biological: Influenza vaccine

The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.

Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population





Primary Outcome Measures :
  1. Influenza hemagglutination inhibition (HAI) titer [ Time Frame: 4 weeks post vaccination ]
    immunological vaccine response


Secondary Outcome Measures :
  1. Clinical efficacy of vaccine [ Time Frame: through study completion, an average of 2 years ]
    decreased influenza rates



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 3-22 years
  • Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:

    • TNF inhibitors [etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)]
    • anti IL -1 [anakinra (Kineret®) or canakinumab (Ilaris®)]
    • IL-6 tocilizumab (Actemra®)
    • anti IL-12/23 ustekinumab (Stelara®)
    • anti CTLA-4 [abatacept (Orencia®)]
    • vedolizumab (Entyvio®)
    • azathioprine (Imuran®)
    • 6 mercaptopurine (Purinethol®)
    • Cyclosporine
    • Leflunomide
    • Mycophenolate
    • methotrexate (Otrexup® or Rasuvo®)

Exclusion Criteria:

  • Prior allergic reaction to any vaccine components
  • Other contraindication to influenza vaccination
  • Severe egg allergy
  • Pregnancy
  • Prior Guillain-Barre syndrome
  • Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
  • Prior rituximab
  • Prior cyclophosphamide
  • Prior IVIG within 8 weeks
  • Acute febrile illness at time of study evaluation
  • No prior history of two doses of influenza in the past for ages 3-8 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277703


Contacts
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Contact: Christy A Beneri, DO (631) 444-7692 Christy.Beneri@stonybrookmedicine.edu
Contact: Julie Cherian, MD (631) 444-7884 Julie.Cherian@stonybrookmedicine.edu

Locations
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United States, New York
Clinical Research Center Recruiting
East Setauket, New York, United States, 11733
Contact: Wendy Mattias, RN    631-444-6900    wendy.mattias@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
University of North Carolina, Chapel Hill

Publications:

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Responsible Party: Christy Beneri, Assistant Professor of Pediatrics, Stony Brook University
ClinicalTrials.gov Identifier: NCT03277703     History of Changes
Other Study ID Numbers: 1077651
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christy Beneri, Stony Brook University:
Influenza vaccine
Booster dose
immunocompromised
Biologic therapy
Rheumatologic disease
inflammatory bowel disease
Additional relevant MeSH terms:
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Rheumatic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Collagen Diseases
Immune Complex Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Connective Tissue Diseases
Musculoskeletal Diseases
Hypersensitivity
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs