Flu Vaccine
Conditions
Keywords
adult 65 and older
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.
Interventions
BIOLOGICALFluzone-High Dose Quadrivalent
Seasonal influenza vaccination with FDA approved vaccines for this age group.
BIOLOGICALFluad
Adjuvanted (MF59) inactivated influenza vaccine
BIOLOGICALFlublock
Recombinant hemagglutinin vaccine
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 125 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutinin Antigen Inhibition Assay Titers at Baseline | 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)) |
| Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | 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)) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluzone-High Dose FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group. | 2 |
| Fluad Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine | 2 |
| Recombinant Hemagglutinin Vaccine (Flublok) Recombinant hemagglutinin vaccine
Flublock: Recombinant hemagglutinin vaccine | 6 |
| Total | 10 |
Baseline characteristics
| Characteristic | Fluzone-High Dose | Total | Recombinant Hemagglutinin Vaccine (Flublok) | Fluad |
|---|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 1.6 | 69.5 years STANDARD_DEVIATION 4.7 | 72.1 years STANDARD_DEVIATION 5.1 | 70.5 years STANDARD_DEVIATION 2.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 10 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 6 |
Outcome results
Primary
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))
Time frame: Baseline Baseline
Population: 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Brisbane/2018 (H1N1) | 20 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Kansas/2017 (H3N2) | 40 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Colorado/2017 (Vic) | 160 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Phuket/2013 (Yam) | 320 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Phuket/2013 (Yam) | 160 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Brisbane/2018 (H1N1) | 160 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Colorado/2017 (Vic) | 240 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Kansas/2017 (H3N2) | 90 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Phuket/2013 (Yam) | 100 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Kansas/2017 (H3N2) | 50 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | B/Colorado/2017 (Vic) | 120 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Baseline | A/Brisbane/2018 (H1N1) | 25 antibody titers |
Primary
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))
Time frame: Day 28 Baseline
Population: 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Brisbane/2018 (H1N1) | 320 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Kansas/2017 (H3N2) | 2560 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Colorado/2017 (Vic) | 640 antibody titers |
| Fluzone-High Dose | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Phuket/2013 (Yam) | 320 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Phuket/2013 (Yam) | 160 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Brisbane/2018 (H1N1) | 120 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Colorado/2017 (Vic) | 320 antibody titers |
| Fluad | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Kansas/2017 (H3N2) | 160 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Phuket/2013 (Yam) | 240 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Kansas/2017 (H3N2) | 320 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | B/Colorado/2017 (Vic) | 480 antibody titers |
| Recombinant Hemagglutinin Vaccine (Flublok) | Hemagglutinin Antigen Inhibition Assay Titers at Day 28 | A/Brisbane/2018 (H1N1) | 480 antibody titers |