Clinical trial NCT02933723: Immunogenicity of Influenza Vaccine in Long Term Care
Official title: Comparison of Immunogenicity of Adjuvanted and Non-Adjuvanted Influenza Vaccination in a Long-Term Care Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
Keywords: influenza vaccine
nursing home
influenza
vaccination
immunity
cell-mediated immunity
humoral immunity
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: University Hospitals Cleveland Medical Center
name: Seqirus
First posted: 2016-10-14
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hemagglutination inhibition (HAI)
timeFrame: day 0 and day 28 +/-3 days
measure: Change in microneutralization (MN)
timeFrame: day 0 and day 28 +/-3 days
Secondary outcomes:
measure: Change in cell mediated immunity (CMI) - IFN-gamma
timeFrame: day 0 and day 7 +/-1 day
measure: Change in cell mediated immunity (CMI) - IL-10
timeFrame: day 0 and day 7 +/-1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Insight Therapeutics, LLC
name: H. Edward Davidson, PharmD
role: STUDY_DIRECTOR
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