Influenza
Conditions
Keywords
influenza vaccine, nursing home, influenza, vaccination, immunity, cell-mediated immunity, humoral immunity
Brief summary
The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.
Detailed description
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.
Interventions
PROCEDUREBlood Draw
Sampling 3 blood draws Day 0 for humoral and CMI 30 ml prior to vaccination (up to 2 week prior to vaccination) Day 7 for CMI 20 ml (+/- 1 day) Day 28 for humoral 10 ml (+/- 3 days)
Sponsors
Case Western Reserve University
University Hospitals Cleveland Medical Center
Seqirus
Insight Therapeutics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemagglutination inhibition (HAI) | day 0 and day 28 +/-3 days | Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific Hemagglutination Inhibition (HAI) |
| Change in microneutralization (MN) | day 0 and day 28 +/-3 days | Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific microneutralization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cell mediated immunity (CMI) - IFN-gamma | day 0 and day 7 +/-1 day | Fold change in IFN-gamma (pg/mL) from day 0 to day 7 for vaccine strain-specific T cells |
| Change in cell mediated immunity (CMI) - IL-10 | day 0 and day 7 +/-1 day | old change in IL-10 (pg/mL0 from day 0 to day 7 for vaccine strain-specific T cells |
Countries
United States
Outcome results
None listed