An interventional study of Blood Draw in Influenza, sponsored by Insight Therapeutics, LLC. Status unknown at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Insight Therapeutics, LLC · Not applicable, Interventional, and Basic science
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 200 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Insight Therapeutics, LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
individuals who received adjuvanted trivalent influenza vaccine (aTIV, Fluad) and consent to a blood draw
Procedure: Blood Draw
individuals who received nonadjuvanted trivalent influenza vaccine and consent to a blood draw
Procedure: Blood 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)
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)
Time frame: 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
Time frame: day 0 and day 28 +/-3 days
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
Time frame: 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
Time frame: day 0 and day 7 +/-1 day
Plan to share: No
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Insight Therapeutics, LLC