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Flu Vaccine Response in Patients on Biologic Therapies

Primary Purpose

Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatologic Disorder focused on measuring Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease

Eligibility Criteria

3 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 - Booster

Group 2 - Standard

Arm Description

Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2.

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.

Outcomes

Primary Outcome Measures

Influenza hemagglutination inhibition (HAI) titer
immunological vaccine response

Secondary Outcome Measures

Clinical efficacy of vaccine
decreased influenza rates

Full Information

First Posted
August 30, 2017
Last Updated
February 23, 2022
Sponsor
Stony Brook University
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03277703
Brief Title
Flu Vaccine Response in Patients on Biologic Therapies
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatologic Disorder, Inflammatory Bowel Diseases, Immune Complex Diseases
Keywords
Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Booster
Arm Type
Experimental
Arm Description
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2.
Arm Title
Group 2 - Standard
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
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 Measure Information:
Title
Influenza hemagglutination inhibition (HAI) titer
Description
immunological vaccine response
Time Frame
4 weeks post vaccination
Secondary Outcome Measure Information:
Title
Clinical efficacy of vaccine
Description
decreased influenza rates
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Clinical Research Center
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25227771
Citation
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Citation
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Flu Vaccine Response in Patients on Biologic Therapies

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