Influenza Vaccines for Older Adults
Recruiting in Palo Alto (17 mi)
+2 other locations
AS
Overseen byAlbert Shaw, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Yale University
Must not be taking: Antibiotics
Disqualifiers: Acute infection, Cancer treatment, Pregnancy, Transplant history, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study will compare the immune response signatures (including immunologic, transcriptomic and metabolomic) of the two influenza vaccines approved for use in adults age 65 and over (Fluad and Fluzone High-Dose).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are currently using antibiotics for an acute infection, you will not be eligible to participate.
What makes the influenza vaccines Fluad and Fluzone unique for older adults?
Fluad and Fluzone are unique because they are specifically designed for older adults, with Fluad containing an adjuvant (an ingredient that helps boost the body's immune response) and Fluzone being a high-dose vaccine, both aimed at providing better protection against influenza in this age group.12345
Research Team
AS
Albert Shaw, MD, PhD
Principal Investigator
Yale University
Eligibility Criteria
This trial is for adults aged either 21-30 or over 65 who plan to stay in New Haven, CT for the next month or so. They must understand and agree to participate. It's not for pregnant individuals, those on recent antibiotics due to acute infections, people who've donated a lot of blood recently, have missed many appointments, had bad reactions to flu shots before, are on trial meds, have an infection currently, cancer treatments recently or severe chronic diseases.Inclusion Criteria
Plan to be in the New Haven, CT area for the next 4-6 weeks
I am either between 21-30 years old or 65 and older.
I can understand and agree to the study, or someone can consent for me if I'm unable.
Exclusion Criteria
Blood donation of 1 pint or more in past 2 months
I have not received cancer treatment in the last 3 months.
I am currently taking medication as part of a clinical trial.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the high-dose Fluzone or the standard-dose Fluad vaccine
4 weeks
1 visit (in-person) for vaccination
Follow-up
Participants are monitored for immune response and safety post-vaccination
10 weeks
Multiple visits for assessments at Day 2, 7, 28, and 70
Treatment Details
Interventions
- Fluad (Virus Vaccine)
- Fluzone (Virus Vaccine)
Trial OverviewThe study is looking at how two different flu vaccines (Fluad and Fluzone High-Dose) approved for older adults affect the body's immune response. Researchers will examine changes in immune cells and substances they produce after vaccination.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: ≥65 years standard dose FluadExperimental Treatment1 Intervention
Participants age ≥65 years will receive standard dose Fluad
Group II: ≥65 years high dose FluzoneExperimental Treatment1 Intervention
Participants age ≥65 years will receive high dose Fluzone
Group III: 21-30 standard dose FluadActive Control1 Intervention
Participants age 21-30 years will receive the standard dose Fluad
Group IV: 21-30 high dose FluzoneActive Control1 Intervention
Participants age 21-30 years will receive the high dose Fluzone
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale School of MedicineNew Haven, CT
Yale Health PlanNew Haven, CT
Yale New Haven HospitalNew Haven, CT
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Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Trials
1963
Patients Recruited
3,046,000+
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Trials
3361
Patients Recruited
5,516,000+
Findings from Research
In a 12-week study involving 242 children aged 4 to 11 with persistent asthma, both once-daily and twice-daily doses of dry powder fluticasone propionate (200 microg) significantly improved lung function and asthma symptoms compared to placebo.
Fluticasone propionate was well tolerated over 64 weeks, with minimal adverse effects, suggesting it is a safe and effective treatment option for managing asthma in children.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma.LaForce, CF., Pearlman, DS., Ruff, ME., et al.[2015]
The study aimed to determine if a lower dose combination inhaler of salmeterol and fluticasone (50/250 microg) could provide similar benefits in treating moderate to severe COPD as the higher dose (50/500 microg) inhaler, particularly in improving lung function and reducing exacerbations.
Previous studies have shown that the higher dose inhaler improves forced expiratory volume (FEV1), quality of life, and decreases exacerbations, but most were conducted for less than a year, highlighting the need for longer-term data on the lower dose's efficacy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005.Rustscheff, S., Rydén, L.[2017]
In a 12-month study involving patients with mild to moderate asthma, the once-daily inhalation of fluticasone furoate/vilanterol (FF/V) significantly reduced the exacerbation rate from 1.05 to 0.18 per patient, demonstrating its efficacy in managing asthma symptoms over time.
The treatment also led to a substantial decrease in hospitalization rates, from 0.30 to 0.03 per patient, along with reduced visits to general practitioners and specialists, indicating improved overall health and management of asthma.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Fluticasone furoate/vilanterol 92/22 µg once a day: a 12-month study on outcomes in mild to moderate asthma.Dal Negro, RW., Bonadiman, L., Turco, P.[2019]
The exhalation delivery system Xhance® delivers fluticasone propionate more effectively to the nasal cavity compared to conventional nasal sprays like Flonase®, resulting in higher systemic exposure with lower risk of drug loss through drip-out or swallowing.
In a study involving 90 healthy subjects and 30 asthma patients, Xhance® showed significantly higher peak drug levels (Cmax) than Flonase® at similar doses, indicating its potential for improved efficacy, while still maintaining low systemic exposure compared to inhalational aerosols like Flovent® HFA.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol.Messina, JC., Offman, E., Carothers, JL., et al.[2020]
References
Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma. [2015]
Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005. [2017]
Fluticasone furoate/vilanterol 92/22 µg once a day: a 12-month study on outcomes in mild to moderate asthma. [2019]
Patient considerations in the treatment of COPD: focus on the new combination inhaler fluticasone furoate/umeclidinium/vilanterol. [2020]
A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol. [2020]