Proteomic Profiling for Influenza Vaccination - FluMist

Completed · Phase 4

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00385281

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

2006-10-01

Expected to finish

2007-04-01

Last updated by the study team

2010-08-27

Who can join

Age: 21 and older, up to 49. Sex: any. Healthy volunteers: accepted.

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.
• FluMist recipients in close contact (eg, within the same household) with immunocompromised individuals during periods in which the immunosuppressed person requires care in a protective environment. (contact should be avoided for at least 21 days). Contact with small children is not an exclusion. Females who breastfeed are excluded.
• 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.
• Subject had an acute illness with or without fever (temperature >/= 99.5 F [oral]) in the 72 hours preceding vaccination. Administration of FluMist should be postponed until after the acute phase (at least 72 hours) of febrile and/or acute illnesses.
• Subject has acute or chronic medical health condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to health problems associated with
• heart disease, (if heart failure is present, New York Heart Association Functional Class III or IV),
• kidney disease, (history of significant renal impairment e.g., dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease),
• chronic liver disorders (e.g. hepatitis B or C),
• diabetes mellitus (excluding diet-controlled diabetes),
• arteriosclerotic event during the 6 months prior to enrollment (eg, history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack),
• functional or anatomic asplenia,
• cancer diagnosed and treated within the past 5 years with chemotherapy, radiation therapy and/or surgery

Where it is running

• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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