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Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Primary Purpose

Elderly Immune System

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Flu Vaccine
Sponsored by
Health Sciences North Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly Immune System focused on measuring Influenza Vaccine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Written informed consent provided by the participant
  2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
  3. Willing to receive influenza vaccination

  4. Older cohort has received their influenza vaccine for the previous influenza season

    -

Exclusion Criteria:

  1. Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
  2. Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
  3. Participant has received a community available influenza vaccine for the approaching influenza season

  4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

    -

Sites / Locations

  • Center on Aging, UConn Health
  • Health Sciences North Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flu Vaccine SD

Flu Vaccine HD

Arm Description

Fluzone Standard Dose Influenza Vaccine

Fluzone High Dose Influenza Vaccine

Outcomes

Primary Outcome Measures

Number of Influenza Cases
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2014
Last Updated
July 31, 2018
Sponsor
Health Sciences North Research Institute
Collaborators
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT02297542
Brief Title
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Official Title
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Sciences North Research Institute
Collaborators
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Immune System
Keywords
Influenza Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flu Vaccine SD
Arm Type
Active Comparator
Arm Description
Fluzone Standard Dose Influenza Vaccine
Arm Title
Flu Vaccine HD
Arm Type
Active Comparator
Arm Description
Fluzone High Dose Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
Flu Vaccine
Other Intervention Name(s)
Fluzone HD
Primary Outcome Measure Information:
Title
Number of Influenza Cases
Description
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent provided by the participant Age 20-40 years old with no underlying chronic diseases or age ≥65 years old Willing to receive influenza vaccination Older cohort has received their influenza vaccine for the previous influenza season - Exclusion Criteria: Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily) Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination Participant has received a community available influenza vaccine for the approaching influenza season Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet E McElhaney, MD
Organizational Affiliation
Health Sciences North Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Aging, UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Health Sciences North Research Institute
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35128529
Citation
McElhaney JE, Verschoor CP, Haynes L, Pawelec G, Loeb M, Andrew MK, Kuchel GA. Key Determinants of Cell-Mediated Immune Responses: A Randomized Trial of High Dose Vs. Standard Dose Split-Virus Influenza Vaccine in Older Adults. Front Aging. 2021 May;2:649110. doi: 10.3389/fragi.2021.649110. Epub 2021 May 21. Erratum In: Front Aging. 2021 Jun 25;2:718966.
Results Reference
derived

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Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

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