Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine

By looking at the immune response before and after vaccine, we hope to understand the
factors that determine the immune response and detailed shedding patterns of live novel H1N1
vaccine.

Inclusion Criteria:

- Aged 18-32 years, inclusive

- No history of Novel H1N1 virus or vaccine

- Female not able to bear children or not pregnant and agrees to practice effective
birth control

- Female negative pregnancy test

- Good Health

- Ability to understand and comply with protocol

- Provided Informed Consent

Exclusion Criteria:

- Previous history of vaccination against novel H1N1 or laboratory documented H1N1
infection

- History of egg allergy or is allergic to other components of the vaccine

- A women who is pregnant or breastfeeding or intends to get pregnant during the study
period between enrollment and 30 days following vaccination

- Subject is immunosuppressed as the result of underlying illness or treatment with
immunosuppressive or cytotoxic drugs or use of chemotherapy or radiation therapy in
the preceding 36 months

- Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate
cancer that is stable in the absence of therapy) or a history of any hematological
malignancy. "active is defined as treatment within the past 5 years

- Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose
inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within
the preceding 6 months (nasal and topical steroids allowed)

- Received immunoglobulin or another blood product within 3 months prior to enrollment
in this study

- Subject has received an inactivated vaccine within 2 weeks or a live vaccine within 4
weeks prior to enrollment in this study or plans to receive another vaccine within
the next 28 days (or 56 days for the vaccine naive recipients)

- Subject has an acute or chronic medical condition that, in the opinion of the
investigator, would render vaccination unsafe or would interfere with the evaluation
of responses. Those conditions include chronic conditions recognized as risk factors
for influenza complications or as contraindicated for live vaccination, including
chronic cardiac (exclusive of hypertension) or pulmonary conditions (including
asthma), diabetes mellitus, or renal impairment

- Subject has an acute illness or an oral temperature greater then 99.9 degrees F(37.7
C)within 3 days prior to enrollment or vaccination. Subject who has acute illness
that was treated, symptoms resolved are eligible to enroll as long as treatment is
complete and symptoms resolved > 3 dyas prior to enrollment.

- Subject is currently participating or plans to participate in a study that involves
an experimental agent (vaccine, drug, biologic, device, blood product, or medication)
or has received an experimental agent within 1 month prior to enrollment in this
study, or intends to donate blood during this period.

- Subject has any condition that would, in the opinion of the site investigator, place
the subject at an unacceptable risk of injury or render the subject unable to meet
the requirements of the protocol

- Subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.

- Subject has known human immunodeficiency virus, hepatitis B, or hepatitis C
infection.

- Subject has a previous history of Guillain-Barre syndrome within 6 weeks of receipt
of influenza vaccine

- Subject has any condition that the principal investigator (PI) believes may interfere
with the successful completion of the study