Senescent Immunity in Elders and Vaccine Responses (SILVER)
Single Cell Molecular Analysis of Influenza Vaccine Induced T Cell Responses in Adults 65 Years of Age or Older
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedResults Posted
Study results publicly available
July 12, 2022
CompletedJuly 12, 2022
June 1, 2022
3 months
August 30, 2019
June 16, 2022
June 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Fluzone-High Dose
ACTIVE COMPARATORFDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluad
ACTIVE COMPARATORAdjuvanted (MF59) inactivated influenza vaccine (Fluad)
Recombinant Hemagglutinin vaccine (Flublok)
ACTIVE COMPARATORRecombinant hemagglutinin vaccine
Interventions
Seasonal influenza vaccination with FDA approved vaccines for this age group.
Adjuvanted (MF59) inactivated influenza vaccine
Recombinant hemagglutinin vaccine
Eligibility Criteria
You may qualify if:
- Age 65 years and over
- Independent Living (including Assisted Living)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Spyros Kalams, MD
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Spyros Kalams
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Infectious Disease
Study Record Dates
First Submitted
August 30, 2019
First Posted
September 4, 2019
Study Start
October 21, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
July 12, 2022
Results First Posted
July 12, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- 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.
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.