Immunogenicity of Influenza Vaccine in Long Term Care

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02933723
Study type	Interventional
Source	Insight Therapeutics, LLC
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 2016
Completion date	September 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05523089` - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults	Phase 2
Completed	`NCT05009251` - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake	N/A
Completed	`NCT03282240` - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US	Phase 3
Completed	`NCT00968539` - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00968526` - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00971425` - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)	Phase 3
Completed	`NCT05525494` - Patient Portal Flu Vaccine Reminders (5)	N/A
Completed	`NCT04074928` - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects	Phase 3
Completed	`NCT04695717` - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam	Phase 3
Completed	`NCT05012163` - Lottery Incentive Nudges to Increase Influenza Vaccinations	N/A
Completed	`NCT04109222` - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively	Phase 4
Completed	`NCT03888989` - Response to Influenza Vaccine During Pregnancy	Phase 1
Completed	`NCT02587221` - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age	Phase 3
Completed	`NCT03453801` - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection	Phase 1
Completed	`NCT01440387` - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older	Phase 3
Terminated	`NCT01195779` - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children	Phase 2
Completed	`NCT03321968` - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults	Phase 3
Completed	`NCT00972517` - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children	Phase 3
Completed	`NCT04570904` - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting	`NCT03331991` - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel	N/A