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OpenTrials
Completed

NCT Number: NCT04077424

Senescent Immunity in Elders and Vaccine Responses (SILVER)

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.

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Key information

Conditions

Flu Vaccine Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year–125 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluzone-High Dose Quadrivalent

Biological

Seasonal influenza vaccination with FDA approved vaccines for this age group.

Other names: High-dose flu vaccine

Fluad

Biological

Adjuvanted (MF59) inactivated influenza vaccine

Other names: standard-dose, inactivated influenza (flu) vaccine

Flublock

Biological

Recombinant hemagglutinin vaccine

Other names: Recombinant Hemagglutinin vaccine

Primary outcomes

  1. 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))

  2. 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))

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2019
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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