The purpose of this study is to investigate the effect of different licensed influenza
vaccines including 2011-2012 formulation of trivalent inactivated influenza vaccine (TIV)
delivered by different routes intramuscular(IM) and intradermal(ID) and 2011-2012
formulation of live attenuated influenza vaccine (LAIV) administered intranasally
administered in generally healthy male and female volunteers. The goal is to develop and
apply assays to characterize the human immune response to influenza vaccination, and to
compare responses to mucosal vs. systemic vaccination.
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Inclusion Criteria:
- Otherwise healthy, ambulatory between the ages of 18-49 years, inclusively.
- Willing to complete the informed consent process
- Availability for follow-up for the planned duration of the study at least 28 days
after immunization
- Acceptable medical history and vital signs
Exclusion Criteria:
- Prior vaccination with 2010-2011 seasonal TIV or LAIV
- Prior off-study vaccination with TIV or LAIV in the current flu season
- Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose
vials only)
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on the day
of vaccination
- Asthma or history of wheezing (for volunteers receiving LAIV only)
- Participants in close contact with anyone who has a severely weakened immune system
should not receive LAIV (for volunteers receiving LAIV only)
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function, including, but not limited to,
clinically significant liver disease, diabetes mellitus treated with insulin,
moderate to severe renal disease, or any other chronic disorder which, in the opinion
of the investigator, might jeopardize volunteer safety or compliance with the
protocol
- Blood pressure >150 systolic or >95 diastolic at first study visit
- Chronic Hepatitis B or C
- Recent or current use of immunosuppressive medication, including systemic
glucocorticoids (corticosteroid nasal sprays, inhaled steroids and topical steroids
are permissible in both groups)
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors
such as breast cancer or prostate cancer with recurrence in the past year, and any
hematologic cancer such as leukemia)
- Autoimmune disease (including rheumatoid arthritis) treated with immunosuppressive
medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion
of the investigator, might jeopardize volunteer safety or compliance with the
protocol
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular
medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
agents such as aspirin (except up to 325 mg. aspirin per day), Plavix, or Aggrenox
must be reviewed by investigator to determine if this would affect the volunteer's
safety
- Receipt of blood or blood products within the past 6 months or planned receipt of
blood products prior to completion of study visits
- Medical or psychiatric condition or occupational responsibilities that preclude
participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination
prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Live, attenuated vaccine within 60 days of vaccination or planned non-study
vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Need an allergy immunization (that cannot be postponed) during the study period V01
to V03 (~Day 28)
- History of Guillain-Barré Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to enrollment or planned use of
investigational agents prior to completion of study visits
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or
planned blood donation prior to completion of study visits
- Any condition which, in the opinion of the investigator, might interfere with
volunteer safety, study objectives or the ability of the participant to understand or
comply with the study protocol