T-cell Response-Flu Risk in Older Adults

NCT00138398 | Completed

• 1 other identifier: 05-0056
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how the immune system changes with aging and makes influenza a more serious illness in older people. Influenza vaccination not only can protect people from getting the flu but also can lessen the severity of the illness. This is particularly true for people with congestive heart failure (CHF). This research may provide information that could eventually lead to a new laboratory test that will predict how effective vaccination is for preventing influenza illness in older people. Volunteer participants in this study will include the following groups: 1) healthy young adults 20 - 40 years old; 2) older adults, 60 years and older, without a history of CHF; 3) older adults, 60 years and older, with a history of CHF. All study participants will be vaccinated with the current preparation of inactivated influenza vaccine. A small amount of blood will be drawn before each vaccine and at 4, 10, and 16-20 weeks afterward.

Conditions

Influenza

Keywords

Influenza, T cell, vaccine, Congestive heart failure

Interventions

Commercial TriValent Split Influenza Virus BIOLOGICAL

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to be vaccinated with the current influenza vaccine.
• Healthy young adults are 20-40 years and have no underlying chronic diseases.
• 'Healthy' older adult participants are age 60 and older who may have underlying chronic diseases but no diagnosis of CHF, advanced kidney disease or diabetes requiring insulin.
• High-risk older adults with cardiovascular disease are age 60 years and older and have a diagnosis of CHF, or IHD including ACS in the previous winter season.

You may not qualify if:

• Allergic reactions to eggs or preservatives such as those contained in contact lens solutions.
• A previous significant reaction to vaccination or if they refuse to receive influenza vaccination.
• Known immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily) or have not received influenza vaccination in the past.
• Subjects who report respiratory illness within the two-week period prior to vaccination. Subjects reporting respiratory symptoms at the first study visit are re-scheduled to a time when they have not had a respiratory illness (at least two symptoms of cough, runny nose, malaise and fever) within the two-week period prior to vaccination.
• Cardiovascular diseases due to intravenous drug abuse, myocarditis or congenital abnormalities
• Any condition that in the opinion of the investigator would interfere with the interpretation or the evaluation of the vaccine

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Influenza, Human; Heart Failure

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: October 25, 2005
• Last Updated: February 15, 2019

Record last verified: 2013-02

Locations

US (1)