NCT03277703

Flu Vaccine Response in Patients on Biologic Therapies

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 3 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatologic Disorder
• Inflammatory Bowel Diseases
• Immune Complex Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-03
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2017-09-11
• Last updated: 2022-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study