Senescent Immunity in Elders and Vaccine Responses (SILVER)

Phase 4

Completed

• Conditions: Flu Vaccine
• Interventions: Biological: Flublock; Biological: Fluzone-High Dose Quadrivalent; Biological: Fluad

• Registration Number: NCT04077424
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

To study the effects of age on the immune system's response to flu vaccine and to study the connection between the immune system and physical and cognitive changes associated with aging.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-04
• Study Start: 2019-10-21
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Disposition First Submitted: 2021-03-17
• Disposition First Submitted QC: 2021-09-20
• Disposition First Posted: 2021-09-30
• Status Verified: 2022-06
• Results First Submitted: 2022-06-16
• Results First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Results First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age 65 years and over
• Independent Living (including Assisted Living)

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Exclusion Criteria

• Unable to understand the consent or the study.
• Allergic to any vaccine components, excluding eggs.
• History of Guillain-Barre.
• Residing in a long -term care facility such as a nursing home.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Hemagglutinin vaccine (Flublok)	Flublock	Recombinant hemagglutinin vaccine
Fluzone-High Dose	Fluzone-High Dose Quadrivalent	FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluad	Fluad	Adjuvanted (MF59) inactivated influenza vaccine (Fluad)

Primary Outcome Measures

Name	Time	Method
Hemagglutinin Antigen Inhibition Assay Titers at Day 28	Day 28 Baseline	2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination.; Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Hemagglutinin Antigen Inhibition Assay Titers at Baseline	Baseline Baseline	2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination.; Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States