Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)
Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017)
In this study the investigators are trying to understand how immune function declines in the
 elderly using annual influenza vaccinations as a model system. The longitudinal study began
 in 2007 and continued through early 2017.
Participants ranging in age from 18 to 100 at time of initial enrollment will be immunized
 annually with the seasonal influenza vaccine, Fluzone, on Day 0. Follow-up visits will be
 conducted on Day 6-8 and Day 28. Unsolicited adverse events are collected from immunization
 until the Day 28 visit, serious adverse events are collected for the entire time of study
 participation. A blood sample is collected pre-immunization and at each follow-up visit.
 Volunteers will be followed for up to 11 years, those too frail to come in for visits
 received annual phone calls to monitor health. Last annual influenza vaccines were given in
 Fall 2015.

 The main basic research effort will be to collect safety data and follow medical history
 events in elderly and younger control subjects. Investigators will also look at immune
 responses to influenza vaccination. In 2008, 2012 and 2014, the cohort added additional
 participants to replace those who had withdrawn.

 Beginning in 2014, those participants 65 years and older were immunized with High Dose
 trivalent Fluzone and younger participants received the quadrivalent formulation of Fluzone.
Inclusion Criteria:

 -  Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment

 -  General good health and ambulatory at time of enrollment

 -  No acute illness at time of vaccination

 -  Willing and able to sign Informed Consent

 -  Available for follow-up for the planned duration of the study

 -  Acceptable medical history by screening evaluation and brief clinical assessment

 -  All female subjects of childbearing potential must use an acceptable method of
 contraception and not become pregnant for the duration of the clinical phase of the
 study (approximately 1 month to completion of Visit 3). (Acceptable contraception may
 include implants, injectables, combined oral contraceptives, effective intrauterine
 devices (IUDs), sexual abstinence, or a vasectomized partner).

 Exclusion Criteria:

 -  Prior off-study vaccination with trivalent or quadrivalent (depending no year)
 influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the
 current flu season

 -  Allergy to egg or egg products

 -  Allergy to vaccine components, including thimerosal

 -  Active systemic or serious concurrent illness, including febrile illness on the day of
 vaccination

 -  History of immunodeficiency

 -  Any 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 Visit 1

 -  Chronic Hepatitis B or C.

 -  Recent or current use of systemic immunosuppressive medication, including
 glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible).
 Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review
 by the investigator.

 -  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 or hemoglobinopathies requiring regular medical follow up
 or hospitalization during the preceding year

 -  Use of anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet
 agents such as aspirin, Plavix, 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

 -  Medical or psychiatric condition or occupational responsibilities that preclude
 subject compliance with the protocol

 -  Receipt of inactivated vaccine within 14 days prior to vaccination

 -  Receipt of live, attenuated vaccine within 60 days of vaccination

 -  History of Guillain-Barré Syndrome

 -  Pregnant or lactating woman

 -  Use of investigational agents within 30 days prior to enrollment

 -  Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment

 -  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.