Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT02675608
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2016-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Efficacy in Diabetic and Elderly Patients
Sponsor:
Tulane University
Organization:
Study Overview
Official Title:
Vaccine Efficacy in Diabetic and Elderly Patients
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the effectiveness of the seasonal flu vaccine in adults of different ages and diabetic disease statuses. These studies will help our understanding of how chronic inflammatory diseases impact immunologic function and future research on mitigation strategies.
Detailed Description:
Our goal is to determine if an individual's level of inflammation determines their response to vaccination. The aging process and certain diseases, like type-2 diabetes, have been characterized as chronic inflammatory conditions. These individuals have higher rates of influenza disease and health care costs; hence, yearly vaccination is recommended. There is a paucity of information comparing vaccination in these high-risk groups and identifying biomarkers that can predict vaccine efficacy. The investigators hypothesize that elderly and diabetic patients have reduced responses to seasonal influenza vaccination that are inversely proportional to their level of chronic inflammation. In this pilot proposal, the investigators will examine adult and elderly diabetic and non-diabetic adults for markers of inflammation and vaccine efficacy before and after influenza vaccination. These studies will help our understanding of how chronic inflammatory diseases impact immunologic function and future research on mitigation strategies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: