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Vaccine
Flu Vaccine Effectiveness in Aging (FluVax3 Trial)
Phase 4
Recruiting
Led By George Kuchel, MD, FRCP
Research Sponsored by The Jackson Laboratory
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight of 110 lbs or greater
Male or Female, 65 years and older by September 1, 2022
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day1, day 7, day 35, day 180
Awards & highlights
FluVax3 Trial Summary
This trial will study 66 seniors over 3 years to understand why the flu vaccine is less effective in older adults. Blood, nasal, and stool samples will be collected at 16 study visits.
Who is the study for?
This trial is for English-speaking men and women aged 65 or older, weighing at least 110 lbs, who are willing to participate in a three-year study involving 19 visits. Participants must be open to receiving annual flu vaccines and providing blood samples. They should not have severe reactions to past flu vaccines but cannot join if they've had Guillain-Barre syndrome after vaccination, recent other vaccinations, egg allergies, certain chronic diseases, or conditions affecting the immune system.Check my eligibility
What is being tested?
The study aims to understand why older adults may have a reduced response to influenza vaccines by administering different flu shots over three years. It involves regular collection of blood samples as well as nasal swabs and stool samples at specific times during the study period.See study design
What are the potential side effects?
Since this study isn't focused on vaccine safety or tolerability but rather on understanding immune responses in aging populations, it does not specifically address side effects; however typical flu shot side effects can include soreness at injection site, mild fever, fatigue or muscle aches.
FluVax3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 110 lbs.
Select...
I am 65 years old or older as of September 1, 2022.
Select...
I am willing to get the flu vaccine for the next three seasons.
FluVax3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day1, day 7, day 35, day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day1, day 7, day 35, day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Antibody Responses to Influenza Vaccine Year One
Change in Antibody Responses to Influenza Vaccine Year Three
Change in Antibody Responses to Influenza Vaccine Year Two
Secondary outcome measures
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year One
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Three
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Two
+9 moreFluVax3 Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy Older AdultsExperimental Treatment3 Interventions
Will receive FDA-approved influenza vaccine (Fluzone HD Year 1, FLUAD Year 2, TBD Year 3)
Find a Location
Who is running the clinical trial?
University of ChicagoOTHER
1,004 Previous Clinical Trials
819,711 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,171 Total Patients Enrolled
1 Trials studying Aging
60 Patients Enrolled for Aging
The Jackson LaboratoryLead Sponsor
5 Previous Clinical Trials
2,159 Total Patients Enrolled
1 Trials studying Aging
40 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to get any vaccines 2 weeks before and after my flu shots for the next three flu seasons.You are allergic to eggs or any ingredient in the flu vaccine.I am 65 years old or older as of September 1, 2022.I have not received any vaccines within 2 weeks before my flu shot for the 2022-25 seasons.I have received the flu vaccine for the 2022-23 season.I can attend 19 study visits over three years for flu vaccine research.You have a fever higher than 100.3°F (38°C) on the day of vaccination or within 2 days before vaccination.I weigh at least 110 lbs.You have a history of certain medical conditions like chronic infections, cancer needing treatment, heart problems, severe autoimmune disease, diabetes needing insulin, recent major surgery, substance abuse, certain immune system disorders, or other conditions that could affect the study.Your Rockwood Frailty Index score is higher than 0.21.I agree to have my samples genetically tested and shared anonymously for research.I had Guillain-Barre syndrome within 6 weeks after a flu shot.I am willing to get the flu vaccine for the next three seasons.I agree to give blood samples 16 times over 3 years.I've had the flu shot before without any severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Older Adults
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the chief aim of this research endeavor?
"The primary purpose of this investigation, which will be assessed over the course of Baseline, Day 35 and Day 180 is to assess Change in Antibody Responses to Influenza Vaccine Year Three. Additionally, secondary objectives include establishing the Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Two and Year Three using snATAC-seq as well as determining how many genes are upregulated by both FLUAD and CDC recommended FDA approved influenza vaccinations via RNA-seq and scRNA-seq respectively."
Answered by AI
What is the sample size of participants involved in this research?
"That is correct. According to clinicaltrials.gov, this research project has been ongoing since August 31st 2022 and is still recruiting participants as of September 15th 2022. 66 individuals are sought from a single site for the trial."
Answered by AI
Are there any unfilled slots in this clinical experiment?
"Clinical trials.gov confirms that this clinical research is presently recruiting participants, having been first posted on August 31st 2022 and last modified September 15th 2022."
Answered by AI
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