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

• INCLUSION CRITERIA:
• Adult males and females between 18 and 49 years of age.
• Females of child-bearing potential must have a negative serum beta-human choriogonadotropin (HCG) on Day -7 and agree to use an effective birth control method for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). All female subjects will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
• Agree to storage of blood, NP swab, and RNA specimens for future research.
• Available for the duration of the study. Subjects must be willing and able to make follow-up visits as specified by the protocol.

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.