Proteomic Profiling for Influenza Vaccination - FluMist

NCT00385281 | Completed Phase 4

• 1 other identifier: 06-0041
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at changes that occur in blood and nasal swab samples after a person's immune system responds to receiving a flu vaccine. The investigators will look at the immune response in 50 healthy volunteers, between 21 and 49 years of age, after they have been vaccinated with 1 dose of a flu vaccine sprayed into the nose. A blood sample and nasal swab of each nostril will be collected from volunteers before they receive the flu vaccination. After receiving the flu vaccine, volunteers will record health changes and daily temperatures on diary cards at home for 21 days. Blood will be drawn and nasal swabs will be collected from each volunteer at each of the 6 study visits. Volunteers will participate in the study for approximately 1 month. This study is being conducted at the Glennan Center for Geriatrics and Gerontology at Eastern Virginia Medical School.

Conditions

Influenza

Keywords

proteomic profiling, influenza, vaccine, FluMist

Interventions

FluMist BIOLOGICAL

Eligibility Criteria

• Age: 21 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is between the ages of 21 to 49 years of age on day of enrollment, visit 1(day 0).
• Provides written informed consent.
• Subject is judged to be healthy on the basis of verbal medical and concomitant medications history and has been medically stable prior to screening
• 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.
• Female is not at risk of pregnancy, based on the following:
• Utilizing adequate method of birth control and agree to continue using this method for at least 1 month after enrollment. Adequate methods of birth control may include hormonal (oral, transdermal, or injectable) or double barrier methods (eg condom with spermicide, vaginal combined ring) or intra-uterine device. If using hormonal method or intra-uterine device, usage should be stable for 1 month prior to vaccination and should continue for 1 month post vaccination.
• Negative urine pregnancy test is required for all females at study entry. Females surgically sterilized (history of tubal ligation or total or subtotal hysterectomy) or post-menopausal for 2 years must still have a negative pregnancy test at time of enrollment.
• Subject should be available through telephone contact and agree to participate in all scheduled visits.

You may not qualify if:

• Adults younger than 21 years of age or 50 years and older
• Subject had physician-diagnosed (preferably by culture) influenza at any time during the past 2 years.
• Subject received an influenza vaccine in the 6 months preceding enrollment in the study
• Subjects who receive any live virus vaccine within one month of enrollment and any inactivated or subunit vaccine within 2 weeks of enrollment or with plans to receive any vaccine during this study will be excluded from the study, eg, pneumococcal vaccine.
• Subject received blood or blood products in the last 3 months.
• Subject has asthma or reactive airway disease.
• Subject has a history of any serious vaccine reactions or anaphylaxis or reactions likely to be exacerbated by any component of the study vaccine,
• Subject is allergic to eggs, egg products or gentamycin.
• Subject has known or suspected disease(s) of the immune system with immunosuppression, eg, rheumatoid arthritis, systemic lupus erythematosus (SLE), lymphoma, human immunodeficiency virus (HIV), cancer diagnoses or treatment within the last 5 years (except skin cancer), etc.
• Subject is currently being treated with an immunosuppressive medications (ie, 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.
• Drug interactions: On antiviral therapy in 48 hours preceding scheduled vaccination
• Antiviral agents administered until 3 weeks after FluMist vaccination.
• Participation in any other interventional drug or vaccine trial within 30 days prior to enrollment. Therefore subject is not to receive other investigational products (drug or vaccine) during the length of their participation in the trial.
• Subject has acute respiratory illness. Administration of FluMist should be postponed until after the acute phase (at least 72 hours) of respiratory illnesses.
• Subject has active infections or illnesses.

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

Interventions

FluMist

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: October 5, 2006
• First Posted: October 9, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 27, 2010

Record last verified: 2010-03

Locations

US (1)