Proteomic Profiling for Influenza

NCT00133588 | Completed Phase 4

• 1 other identifier: 05-0044
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a new method of detecting the flu infection. This method may allow researchers to identify new proteins being made in response to an infection even before symptoms of the infection are present. The goal of this study is not to prevent the flu but to monitor the immune system response. The elderly and those with chronic health problems are at greater risk for complications (i.e., pneumonia, bronchitis \[bacterial infection in the lungs\], and sinusitis \[bacterial infection in the sinuses\]) from the flu. Early detection and diagnosis of the flu decreases the number of people with these complications. Participants will include healthy people between the ages of 21-40, between the ages of 60-89, or 90 years and older, who are living in the communities surrounding the 3 study sites in Virginia. There will be 5 study visits, and subjects will participate up to 1 month.

Conditions

Influenza

Keywords

influenza, vaccine, proteomic profiling, elderly

Interventions

Trivalent split Inf BIOLOGICAL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written informed consent.
• Subject is judged to be healthy on the basis of verbal history.
• Subject is able to attend scheduled visits and to comply with the study procedures during the entire duration of the study and will be available for 1 month after enrollment.
• Females of childbearing potential must agree to use contraception and must agree to continue using this method for at least 3 months after enrollment. All females under the age of 60 must have a negative urine pregnancy test at enrollment. Those that have a history of tubal ligation or hysterectomy or are postmenopausal at least 1 year of no menses may be included but must still have a negative urine pregnancy test at enrollment. Acceptable forms of hormonal contraception include the use of oral contraceptives, injectable contraceptives (ie, Depo-ProveraTM) or transdermal contraceptives for a period of 3 months prior to enrollment.
• Subject must have access to telephone service.

You may not qualify if:

• Subject received an influenza vaccine 6 months preceding enrollment in the study.
• Subject had physician-diagnosed (preferably by culture) influenza at any time during the past 2 years.
• Subject had an acute illness with or without fever (temperature greater than or equal to 99.5ºF \[oral\]) in the 72 hours preceding vaccination.
• Subject received any vaccine 14 days before enrollment or plans to receive any vaccine during this study.
• Subject received blood or blood products in the last 3 months.
• Subject has known or suspected disease(s) of the immune system (ie, rheumatoid arthritis, lupus, lymphoma, human immunodeficiency virus, etc). Stable, controlled osteoarthritis is allowed if medication is only intermittently used for relief of symptoms.
• Subject has underlying unstable chronic disease such as uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg at Visit 1), congestive heart failure, heart attack within the last 6 months, liver, and kidney disease, etc;
• Subject is currently being treated with an immunosuppressive medications (i.e., cancer therapeutic agents such as Tamoxifen, systemic corticosteroids such as Prednisone, and arthritis medications such as Methotrexate). Please note that inhaled or topical corticosteriods are acceptable.
• Subject is pregnant or planning to become pregnant within the next 2 months.
• Subject is breastfeeding.
• Subject has a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine, including a history of anaphylaxis or serious vaccine reaction; subject is allergic to eggs, contact lens solution, or has ever had a severe reaction to any influenza vaccine.
• Subject is allergic to latex rubber;
• Subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• Subject has acute respiratory or other active infections or illnesses.
• Subject has any active neurologic disorders (ie, encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy).

Sponsors & Collaborators

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

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: November 1, 2006
• Study Completion: January 1, 2007
• Last Updated: August 27, 2010

Record last verified: 2007-05

Locations

US (1)