Senescent Immunity in Elders and Vaccine Responses (SILVER)

June 16, 2022 updated by: Spyros Kalams, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 125 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluzone-High Dose
FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Biological: Fluzone-High Dose Quadrivalent
Seasonal influenza vaccination with FDA approved vaccines for this age group.
Other Names:
  • High-dose flu vaccine
Active Comparator: Fluad
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Biological: Fluad
Adjuvanted (MF59) inactivated influenza vaccine
Other Names:
  • standard-dose, inactivated influenza (flu) vaccine
Active Comparator: Recombinant Hemagglutinin vaccine (Flublok)
Recombinant hemagglutinin vaccine
Biological: Flublock
Recombinant hemagglutinin vaccine
Other Names:
  • Recombinant Hemagglutinin vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
Time Frame: 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))
Baseline Baseline
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
Time Frame: 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))
Day 28 Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Spyros Kalams, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • single cell

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication.

IPD Sharing Access Criteria

All relevant findings will be published in peer-reviewed journals and data generated will be presented at national and international meetings. Research articles will be deposited in the NIH National Library of Medicine's PubMed Central upon acceptance for publication. To the extent possible,we will make raw data available in publications (directly or online appendices). If novel techniques are developed and validated, these methods will be shared with the general scientific community in a timely fashion, and also made available via the protocols.io open access platform. As suggested by the NIH , this will be no later than the acceptance for publication of the main findings from the final data set generated within this proposal. If requests for access to data beyond that in our publications are made by members of the scientific community, we will ask that users submit requests for specific analyses, and we will strive to meet all reasonable requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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