Revealing Protective Immunity to Influenza Using Systems Immunology

Inclusion Criteria:

• Able to understand and give informed consent

• Participants of child bearing potential must agree to use effective birth controlfor the duration of the study. A negative urine pregnancy test must be documentedprior to vaccination.

Exclusion Criteria:

• History of allergy or serious adverse reaction, including Guillain-Barré syndrome,to a vaccine or vaccine products

• History of a medical condition resulting in impaired immunity such as active solidtumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmuneconditions, or splenic dysfunction. Persons with previous skin cancers or curednon-lymphatic tumors are not excluded from the study.

• History of asthma, cochlear implant, or active cerebrospinal fluid leak

• Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone > 20mg/day), chronic administration (more than 14 days total) ofimmunosuppressive or immunomodulatory drugs in the prior 3 months

• History of HIV, Hepatitis B or Hepatitis C infection

• Chronic clinically significant medical problems that could be considered active orunstable (i.e diagnosed within the past 3 months or requiring a change in medicationwithin the past 3 months). This is including (but not limited to):

• Insulin dependent diabetes

• Severe heart disease (including arrhythmias)

• Severe lung disease

• Severe liver disease

• Severe kidney disease

• Severe hypertension: defined as life-threatening consequences (e.g., malignanthypertension, transient or permanent neurologic deficit).

• Congenital genetic syndromes (e.g., trisomy 21)

• Body Mass Index (BMI) > 35

• Pregnancy or breast feeding, or plans to become pregnant in the next month

• History of influenza infection or vaccination within the current or previousinfluenza season

• Receipt of blood products or immune globulin product within the prior 3 months

• History of excessive alcohol consumption, drug use, psychiatric conditions, socialconditions or occupational conditions that in the opinion of the investigator wouldpreclude compliance with the trial

• Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination

• Receipt of any inactivated vaccines 14 days before, or plans to receive anyinactivated vaccines 14 days after vaccination

• Receipt of any non-registered or other investigational product in 30 days before, orplans to receive any other investigational product 30 days after vaccination

• Temporary Exclusion Criteria:

• Fever (temperature ≥38.0°C) or coryzal symptoms within 72 hours prior tovaccination

• Receipt of antipyretics within 6 hours prior to vaccination