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 control for the duration of the study. A negative urine pregnancy test must be documented prior 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 solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-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) of immunosuppressive 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 or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within 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., malignant hypertension, 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 previous influenza season
• Receipt of blood products or immune globulin product within the prior 3 months
• History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude 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 any inactivated vaccines 14 days after vaccination
• Receipt of any non-registered or other investigational product in 30 days before, or plans 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 to vaccination
• Receipt of antipyretics within 6 hours prior to vaccination