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

Exclusion Criteria

• •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.
• •Current smoker.
• •Travel to the Southern Hemisphere 30 days prior to study enrollment or anticipated travel to the Southern Hemisphere during the study.
• •Travel on a cruise ship 30 days prior to study enrollment or anticipated travel on a cruise ship during the study.
• •Receipt of another investigational vaccine or drug within 30 days prior to enrollment in the study.