Flu Vaccine Response in Patients on Biologic Therapies

Immune Complex Diseases, Inflammatory Bowel Diseases, Rheumatologic Disorder

Influenza vaccine, Booster dose, immunocompromised, Biologic therapy, Rheumatologic disease, inflammatory bowel disease

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.

Patients receiving immunosuppressive therapies for rheumatologic diseases and inflammatory bowel disease (IBD) are at increased risk of serious infections, including influenza. Infections can also trigger flares of the underlying disease. Although newer biologic treatments are improving disease outcomes, these medications reduce vaccine responses, placing patients at high risk for vaccine-preventable illnesses. In a case-cohort study by Flannery et al. looking at influenza vaccine effectiveness from 2010-2014, only one in four children who died of laboratory-confirmed influenza were vaccinated, while a high prevalence (53%) had an underlying condition that put them at risk for severe influenza-related complications. Yearly influenza vaccination is recommended for all patients with rheumatologic diseases and IBD. However, these recommendations are based on studies that did not include patients receiving newer biologic therapies. Recent studies in organ transplant recipients, a group known to have suboptimal vaccine responses, have suggested a booster influenza vaccine strategy as a way of enhancing vaccine responses. SPECIFIC AIMS: 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.

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United States