Senescent Immunity in Elders and Vaccine Responses (SILVER)

Vanderbilt University Medical Center

Status and phase: Completed; Phase 4

Conditions: Flu Vaccine

Treatments: Biological: Flublock; Biological: Fluzone-High Dose Quadrivalent; Biological: Fluad

Study type: Interventional

Funder types: Other

Identifiers

NCT04077424

single cell

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 65 to 125 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 3 patient groups

Fluzone-High Dose

Active Comparator group

Description:

FDA approved high dose inactivated influenza vaccine (HD-Fluzone)

Treatment:

Biological: Fluzone-High Dose Quadrivalent

Fluad

Active Comparator group

Description:

Adjuvanted (MF59) inactivated influenza vaccine (Fluad)

Treatment:

Biological: Fluad

Recombinant Hemagglutinin vaccine (Flublok)

Active Comparator group

Description:

Recombinant hemagglutinin vaccine

Treatment:

Biological: Flublock