Immunogenicity of Influenza Vaccine in Long Term Care

Not Applicable

• Conditions: Influenza
• Interventions: Procedure: Blood Draw

• Registration Number: NCT02933723
• Lead Sponsor: Insight Therapeutics, LLC

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Primary Completion: 2017-05-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
• Receiving chemotherapy for an active cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood draw- adjuvanted TIV	Blood Draw	individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw
Blood draw - nonadjuvanted TIV	Blood Draw	individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States