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Senescent Immunity in Elders and Vaccine Responses (SILVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077424
Recruitment Status : Completed
First Posted : September 4, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Spyros Kalams, 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.

Condition or disease Intervention/treatment Phase
Flu Vaccine Biological: Fluzone-High Dose Quadrivalent Biological: Fluad Biological: Flublock Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.
Primary Purpose: Basic Science
Official Title: Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older
Actual Study Start Date : October 21, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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 Name: High-dose flu vaccine

Active Comparator: Fluad
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Biological: Fluad
Adjuvanted (MF59) inactivated influenza vaccine
Other Name: standard-dose, inactivated influenza (flu) vaccine

Active Comparator: Recombinant Hemagglutinin vaccine (Flublok)
Recombinant hemagglutinin vaccine
Biological: Flublock
Recombinant hemagglutinin vaccine
Other Name: Recombinant Hemagglutinin vaccine




Primary Outcome Measures :
  1. Hemagglutinin antigen inhibition assay titers at baseline [ Time Frame: Baseline ]
  2. Hemagglutinin antigen inhibition assay titers at Day 28 [ Time Frame: Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 125 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077424


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37211
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Spyros Kalams Vanderbilt University Medical Center
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Responsible Party: Spyros Kalams, Associate Professor Infectious Disease, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04077424    
Other Study ID Numbers: single cell
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spyros Kalams, Vanderbilt University Medical Center:
adult 65 and older
Additional relevant MeSH terms:
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Vaccines
Hemagglutinins
Immunologic Factors
Physiological Effects of Drugs
Agglutinins