Flu Vaccine Response in Patients on Biologic Therapies

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03277703
Study type	Interventional
Source	Stony Brook University
Contact
Status	Completed
Phase	Phase 2
Start date	November 3, 2017
Completion date	January 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04046913` - The ADDapt Diet in Reducing Crohn's Disease Inflammation	N/A
Active, not recruiting	`NCT04989907` - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Active, not recruiting	`NCT04990258` - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed	`NCT06216223` - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients	N/A
Enrolling by invitation	`NCT06015789` - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting	`NCT06065995` - StoMakker Mobile Application	N/A
Recruiting	`NCT03282786` - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease	N/A
Recruiting	`NCT06002074` - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT04960826` - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting	`NCT05413941` - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease	N/A
Completed	`NCT03668249` - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed	`NCT00721812` - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686	Phase 1
Recruiting	`NCT05809999` - IBD Neoplasia Surveillance RCT	N/A
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Recruiting	`NCT04991324` - Cholecalciferol Comedication in IBD - the 5C-study	Phase 3
Completed	`NCT03173144` - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting	`NCT05043818` - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A