Skip to main content
OpenTrials
Completed

NCT Number: NCT03277703

Flu Vaccine Response in Patients on Biologic 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatologic Disorder Collagen Diseases Connective Tissue Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hypersensitivity Immune Complex Diseases Immune System Diseases Infections Inflammatory Bowel Diseases Influenza, Human Intestinal Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Skin and Connective Tissue Diseases Virus Diseases

Age range

3 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Center

East Setauket, New York, 11733, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

influenza vaccine

Biological

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 outcomes

  1. Influenza hemagglutination inhibition (HAI) titer

    Time frame: 4 weeks post vaccination

    immunological vaccine response

Secondary outcomes

  1. Clinical efficacy of vaccine

    Time frame: through study completion, an average of 2 years

    decreased influenza rates

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2017
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.