Immunogenicity of Influenza Vaccine in Long Term Care

Summary: Study investigators will recruit residents of nursing homes that are administering a
licensed influenza vaccine as their standard or care, either the trivalent influenza vaccine
(Fluvirin) or the adjuvanted trivalent influenza vaccine (Fluad). Eligible residents are
those or their legally authorized representatives who give written, informed consent for
three blood draws over one month's time and permission to review their nursing home medical
and administrative records, including information required to be submitted to Medicare
including quality performance data (the Minimum Dataset or MDS) and Medicare claims data for
demographic and underlying disease comparisons between our participating populations between
nursing homes. The investigators propose to study up to 230 subjects in one season at a 1:1
ratio of adjuvanted vs. and non-adjuvanted vaccine.

Background: Influenza is the most common clinically important viral infection of older
adults. Influenza vaccination is associated with reduced hospitalization, strokes, heart
attacks and death in non-institutional older adult populations, but the benefit of influenza
vaccine for the oldest population has been questioned. The adjuvanted vaccine was shown in
the past to elicit higher antibody titers than non-adjuvanted TIV. This included the elderly
population as well. There are far more limited data about cell-mediated immunity (CMI) and
use of the adjuvanted vaccine. There are data that support that CMI is important beyond the
helper function to B cells. CMI helps mitigate influenza disease if the antibodies alone are
not adequately protective.

Objectives: To determine if adjuvanted vaccine elicits higher T cell and B cell responses
than non-adjuvanted standard dose influenza vaccine in nursing home residents.

Inclusion Criteria:

- Resident of Medicare Certified Facility (so they have to report Minimum Data Set (MDS)
data)

- Residence in a long-term care facility administering a Seqirus influenza vaccine as
the standard-of-care.

- Agreed to receive the vaccine that the NH plans to give to them

- >= 65 years old

- Able to obtain consent from subject or legally authorized representative (LAR) and
assent from subject

- Able to participate throughout the study period

- Resident for at least 45 days prior to enrollment

Exclusion Criteria:

- Recent illness (within 30 days) severe enough to require hospitalization or
physician-directed outpatient pharmacotherapy

- Receiving chemotherapy for an active cancer