Flu Vaccine Response in Patients on Biologic Therapies

February 23, 2022 updated by: Christy Beneri, Stony Brook University

Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • East Setauket, New York, United States, 11733
        • Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza hemagglutination inhibition (HAI) titer
Time Frame: 4 weeks post vaccination
immunological vaccine response
4 weeks post vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy of vaccine
Time Frame: through study completion, an average of 2 years
decreased influenza rates
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2017

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (ACTUAL)

September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1077651

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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