Influenza Vaccines for Older Adults

Recruiting at 2 trial locations

Overseen By Irene Matos, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Antibiotics

Disqualifiers: Acute infection, Cancer treatment, Pregnancy, Transplant history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the effects of two flu vaccines, Fluad and Fluzone High-Dose, on the immune system in adults aged 65 and older. Researchers aim to determine which vaccine generates a better immune response by examining various health indicators. Individuals aged 65 and older who plan to stay in the New Haven, CT area for the next 4-6 weeks and have not experienced a recent flu vaccine reaction or certain medical conditions may qualify for this study. As a Phase 2 trial, this research measures the vaccines' effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine development.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Fluad and Fluzone High-Dose vaccines are generally safe for adults aged 65 and older. For Fluad, studies indicate that the most common side effects are mild, including pain at the injection site, reported by 16.3% of participants, and headaches, experienced by 10.8% of participants. Fluad has been tested in over 10,000 older adults and is considered well-tolerated.

Fluzone High-Dose also maintains a good safety record. In older adults, the most common side effect is pain at the injection site. These vaccines are widely used and approved by the FDA for people 65 and older, demonstrating their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, Fluad and Fluzone, because they offer tailored options for older adults, who are more vulnerable to severe flu complications. Unlike standard flu vaccines, Fluzone is designed in a high-dose form, which aims to boost the immune response in people aged 65 and older. This is crucial because immune systems typically weaken with age, making it harder for older adults to fight off infections. On the other hand, Fluad includes an adjuvant, a special ingredient that enhances the body's immune response, potentially making it more effective for seniors. These features may lead to better protection and fewer flu-related health issues in the older population.

What evidence suggests that this trial's treatments could be effective for older adults with influenza?

This trial will compare the effectiveness of different influenza vaccines for older adults. Studies have shown that Fluzone High-Dose, which participants aged 65 and older may receive in this trial, is 24% more effective than the regular flu shot in preventing the flu in this age group. This high-dose vaccine also provides better protection against flu-related hospital visits compared to regular flu shots. Meanwhile, Fluad, another vaccine option in this trial for older adults, significantly enhances flu protection for those aged 65 and up, due to a special ingredient that strengthens the immune response. Overall, both vaccines effectively reduce the risk of flu in older adults, with each offering unique benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Albert Shaw, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Fluad
• Fluzone

Trial Overview

The 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.

How Is the Trial Designed?

Group I: ≥65 years standard dose Fluad Experimental Treatment 1 Intervention

Participants age ≥65 years will receive standard dose Fluad

Group II: ≥65 years high dose Fluzone Experimental Treatment 1 Intervention

Participants age ≥65 years will receive high dose Fluzone

Group III: 21-30 standard dose Fluad Active Control 1 Intervention

Participants age 21-30 years will receive the standard dose Fluad

Group IV: 21-30 high dose Fluzone Active Control 1 Intervention

Participants age 21-30 years will receive the high dose Fluzone

Fluad is already approved in United States, European Union for the following indications:

Approved in United States as FLUAD QUADRIVALENT for:

• Active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine

Approved in European Union as FLUAD for:

• Active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A new inhaler combination of fluticasone furoate, umeclidinium, and vilanterol has been shown to effectively reduce exacerbation rates in patients with stable COPD, based on a large clinical trial.

This combination therapy is safe and convenient, requiring only a single daily administration through a dry powder inhaler, which improves patient adherence and preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient considerations in the treatment of COPD: focus on the new combination inhaler fluticasone furoate/umeclidinium/vilanterol. Molino, A., Calabrese, G., Maniscalco, M.[2020]

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]

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]

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]

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