Studying Cell Immune Responses to a Live Flu Vaccine in Healthy Adults

Completed

Conditions studied: Normal Physiology

In brief

Background: \- One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus. Researchers want to better under how the live vaccine interacts with the body s immune system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt water) nasal spray. They will then look at blood and nasal cell samples to see how the vaccine affects these cells immune response. Objectives: \- To look at immune changes in nasal and blood cells in people who receive live flu vaccine. Eligibility: \- Healthy volunteers between 18 and 49 years of age. Design: * Participants will have five outpatient visits for this study. Each visit will last up to 2 hours. * At the first visit, participants will have a physical exam and medical history. They will give blood and urine samples. Nasal cell samples will also be collected. * A week later, participants will have either the nasal spray flu vaccine or a saline spray. They will know which spray they will receive. Blood samples will be collected. * Two days after the vaccination, they will have another physical exam. Blood and nasal cell samples will be collected. * At the final two visits (1 week and 1 month after the vaccination), more blood samples will be collected. * Those who had the saline spray will be able to have the actual vaccine spray at the last study visit. * The ratio of participants who receive vaccine to those who receive saline will be 4:1.

Key facts

Study ID

NCT01730144

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

10

Starts

2012-11-17

Expected to finish

2019-07-12

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any contraindiciations for adults for the receipt of LAIV:
• -Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine,or life-threatening reactions to previous influenza vaccination.
• Currently breast-feeding.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Clinically significant alanine aminotransferase (ALT) levels, as determined by one of the protocol investigators will be exclusionary at baseline, prior to vaccination.
• Evidence of upper respiratory tract illness (URI) including fever, sore throat, and rhinorrhea. Enrollment of subjects with evidence of URI on Study Day -7 will be temporarily deferred.
• Deviated nasal septum or nasal obstruction.
• Body Mass Index greater than 35.
• NIH employee involved in direct patient care, consistent with the NIH CC policy that employees should avoid patient care for 5 days following receipt of LAIV. In addition, NIH employees must not be under the supervision of the study principal or associate investigators.
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• Seropositive to the influenza A component viruses of seasonal LAIV (serum HAI titer of greater than or equal to 1:10).
• Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the study or would render the subject unable to comply with the protocol.
• History of anaphylaxis.
• Current diagnosis of asthma or reactive airway disease (within the past 2 years).
• History of Guillain-Barr(SqrRoot)(Copyright) Syndrome.
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1).
• Positive ELISA and confirmatory test (e.g., recombinant immunoblotassay) for hepatitis C virus (HCV).
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA.
• Known immunodeficiency syndrome.
• Use of oral, injected, or inhaled corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to enrollment in the study.
• Use of any herbal supplement 30 days prior to study enrollment.
• Receipt of 2012-2013 influenza vaccine (TIV or LAIV).
• Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to enrollment in the study.
• History of a surgical splenectomy.
• Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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