Immunogenicity of Influenza Vaccine in Long Term Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Immunogenicity of Adjuvanted and Non-Adjuvanted Influenza Vaccination in a Long-Term Care Population

Conditions
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Influenza

Intervention / Treatment
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* Procedure: Blood Draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood draw- adjuvanted TIV<br>individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw | Procedure: Blood Draw<br>* 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)<br>|
| Active Comparator: Blood draw - nonadjuvanted TIV<br>individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw | Procedure: Blood Draw<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemagglutination inhibition (HAI) | Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific Hemagglutination Inhibition (HAI) | day 0 and day 28 +/-3 days | 
| Change in microneutralization (MN) | Fold change in antibody titers from day 0 to day 28 as determined by vaccine strain specific microneutralization | day 0 and day 28 +/-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cell mediated immunity (CMI) - IFN-gamma | Fold change in IFN-gamma (pg/mL) from day 0 to day 7 for vaccine strain-specific T cells | day 0 and day 7 +/-1 day | 
| Change in cell mediated immunity (CMI) - IL-10 | old change in IL-10 (pg/mL0 from day 0 to day 7 for vaccine strain-specific T cells | day 0 and day 7 +/-1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, nursing home, influenza, vaccination, immunity, cell-mediated immunity, humoral immunity