Senescent Immunity in Elders and Vaccine Responses (SILVER)

Flu Vaccine Clinical Trial

Official title:

Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077424
• Other study ID #: single cell
• Status: Completed
• Phase: Phase 4
• Start date: October 21, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: June 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 125 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flu Vaccine

Intervention

Biological:
• Fluzone-High Dose Quadrivalent
Seasonal influenza vaccination with FDA approved vaccines for this age group.
• Fluad
Adjuvanted (MF59) inactivated influenza vaccine
• Flublock
Recombinant hemagglutinin vaccine

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutinin Antigen Inhibition Assay Titers at 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))	Baseline Baseline
Primary	Hemagglutinin Antigen Inhibition Assay Titers at Day 28	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))	Day 28 Baseline