Seasonal Influenza Vaccines for Flu

Overseen By James J Kobie, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Disqualifiers: Guillain-Barre, Egg allergy, Malignancy, 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: 6

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants with certain medical conditions and recent vaccinations, so it's best to discuss your specific situation with the trial team.

What makes the seasonal influenza vaccines unique compared to other flu treatments?

The seasonal influenza vaccines like Fluad, Flucelvax, and Fluzone High-Dose are unique because they are specifically designed to target multiple strains of the flu virus in one shot, providing broader protection. They include options like adjuvanted vaccines, which have an added ingredient to boost the body's immune response, and high-dose vaccines, which contain a higher amount of antigen to offer better protection for older adults. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment for seasonal influenza vaccines?

Research shows that high-dose quadrivalent influenza vaccines, like Fluzone High-Dose Quadrivalent, are effective in older adults and children by providing broader protection against different strains of the flu virus. These vaccines are particularly useful in seasons when the predicted flu strains do not match the circulating ones, offering better coverage and safety. ^{6 7 8 9 10}

Who Is on the Research Team?

James J Kobie, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 and 65-80 who can consent to participate. They must weigh at least 110 lbs and not have a history of severe illnesses, recent heart attacks, strokes, or certain chronic diseases like dementia or lupus. Pregnant women, those with egg allergies, bleeding disorders, drug abuse issues (excluding marijuana), or immunodeficiencies are excluded.

Inclusion Criteria

I am between 65 and 80 years old.

I weigh at least 110 lbs.

Able to give informed consent

Exclusion Criteria

I had a moderate to severe illness after getting the flu shot within the last 6 weeks.

Refusal or inability to have blood drawn or participate in study procedures

I have a disorder where my lymphocytes are increasing abnormally.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a single dose of the assigned influenza vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for antibody and B cell responses after vaccination

3 months

2 visits (in-person)

Second Year Vaccination

Participants receive a second dose of the influenza vaccine in the following year

1 day

1 visit (in-person)

Second Year Follow-up

Participants are monitored for antibody and B cell responses after the second year vaccination

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluad
• Flucelvax
• Fluzone
• Fluzone High-Dose

Trial Overview The study tests how different FDA-approved flu vaccines—Flucelvax, Fluzone High-Dose, Fluzone, Fluad—affect antibody responses in younger and older adults. It also looks at the impact of past vaccinations on these responses.

How Is the Trial Designed?

Group I: Fluzone Younger Active Control 1 Intervention

10 adults 18-50 years old, will receive a single dose of the Fluzone influenza vaccine each year for two sequential years

Group II: Flucelvax Active Control 1 Intervention

10 adults 18-50 years old, will receive a single dose of the Flucelvax influenza vaccine each year for two sequential years

Group III: Fluzone Older Active Control 1 Intervention

10 adults 65-80 years old, will receive a single dose of the Fluzone influenza vaccine

Group IV: Fluzone High Dose Active Control 1 Intervention

10 adults 65-80 years old, will receive a single dose of the Fluzone High-Dose influenza vaccine

Group V: Fluad Active Control 1 Intervention

10 adults 65-80 years old, will receive a single dose of the Fluad influenza vaccine

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?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The inactivated quadrivalent influenza vaccine (IIV4) was found to be safe and well-tolerated in a phase III trial involving 1,648 adults and 329 children/adolescents, with no serious adverse events reported.

IIV4 induced strong antibody responses to all four influenza strains it targets, meeting all immunogenicity criteria set by the European Medicines Agency, and showed comparable efficacy to the trivalent vaccine (IIV3) in both age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Cadorna-Carlos, JB., Nolan, T., Borja-Tabora, CF., et al.[2015]

In a study involving 2670 healthy adults aged 65 and older, the quadrivalent high-dose influenza vaccine (IIV4-HD) demonstrated non-inferior immunogenicity compared to the licensed trivalent high-dose vaccine (IIV3-HD) for all four influenza strains.

IIV4-HD showed superior immune responses for both B strains compared to IIV3-HD that did not contain the same B-lineage strain, while maintaining a similar safety profile, indicating it is a more effective option without added safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. Chang, LJ., Meng, Y., Janosczyk, H., et al.[2020]

The high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) has been shown to be safe and effective in preventing influenza in adults aged 65 and older, with improved immunogenicity against additional B strains compared to standard vaccines.

Despite some increased adverse reactions like injection-site pain and myalgia, HD-IIV4 is recommended as the vaccine of choice for older adults due to its superior efficacy compared to other influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. Chahine, EB.[2021]

The quadrivalent influenza vaccine AdimFlu-S showed strong immunogenicity in a study of 174 healthy children aged 3 to 17, achieving high seroprotection rates above 96.4% for all vaccine strains.

The vaccine was well tolerated with no serious adverse events reported over a 6-month follow-up period, indicating it is a safe option for improving protection against different influenza B lineages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. Chang, CY., Cho, CY., Lai, CC., et al.[2021]

The study involving 661 children aged 6 months to under 18 years demonstrated that the high-dose quadrivalent influenza vaccine (IIV4-HD) is safe, with no serious adverse events reported and similar rates of mild reactions compared to the standard-dose vaccine.

IIV4-HD at a dose of 60 µg significantly improved immune responses, particularly in younger children (6 months to <3 years), showing higher antibody titers against various influenza strains compared to the standard-dose vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through Chang, LJ., Anderson, EJ., Jeanfreau, R., et al.[2021]

The fixed-dose combination (FDC) capsule of candesartan cilexetil, hydrochlorothiazide, and rosuvastatin (CC/HCTZ/RSV) demonstrated bioequivalence to the separate tablet formulations in a study involving 24 healthy subjects, indicating similar pharmacokinetics and effectiveness for cardiovascular disease prevention.

All adverse events reported during the study were mild, suggesting that the new FDC capsule formulation is safe and well-tolerated for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new fixed-dose combination of candesartan cilexetil, hydrochlorothiazide, and rosuvastatin in healthy adult subjects. Yerino, GA., Feleder, EC., Halabe, EK., et al.[2022]

The study successfully developed a long orodispersible film (ODF) containing warfarin sodium, which allows for safe and flexible dosing, making it easier for patients to manage their medication.

Using a continuous manufacturing process, the long ODF can be dispensed like tape, enabling individualized therapy for patients of all ages, enhancing the convenience and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulation development of a continuously manufactured orodispersible film containing warfarin sodium for individualized dosing. Niese, S., Quodbach, J.[2019]

The study successfully developed a Flurbiprofen sodium ocusert that enhances local drug delivery, potentially improving patient compliance with eye treatments.

The optimized ocuserts demonstrated stability at room temperature and showed a strong correlation between in vitro and in vivo drug release, indicating effective drug delivery mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of ocusert for controlled delivery of flurbiprofen sodium. Kulhari, H., Pooja, D., Narayan, H., et al.[2016]

The study successfully developed a nanoparticulate, instant orodispersible film (iODF) powder that allows for individualized dosing of active pharmaceutical ingredients (APIs), achieving high drug loads of 11.8 mg/cm² in the final films.

The iODF powders maintain their advantageous properties, including particle size and dissolution profiles, even after being stored for three months at various temperatures, ensuring stability and effectiveness of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instant ODFs - Development of an intermediate, nanoparticle-based product platform for individualized medication. Steiner, D., Finke, JH., Kwade, A.[2018]

Dexamethasone and fludrocortisone acetate are resistant to ionizing radiation at doses of 25-50 kGy, making them suitable for sterilization by radiation, while fluconazole is too sensitive and requires alternative sterilization methods.

Irradiation of these compounds resulted in a decrease in active substance content and the formation of radiolysis products, indicating that while some steroid derivatives can withstand radiation, fluconazole's stability is compromised, highlighting the need for careful selection of sterilization methods based on the compound's properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of fluorine substituent on radiochemical stability of some steroid and azole derivatives]. Marciniec, B., Dettlaff, K., Bafeltowska, J.[2016]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. [2015]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new fixed-dose combination of candesartan cilexetil, hydrochlorothiazide, and rosuvastatin in healthy adult subjects. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Formulation development of a continuously manufactured orodispersible film containing warfarin sodium for individualized dosing. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Design and evaluation of ocusert for controlled delivery of flurbiprofen sodium. [2016]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Instant ODFs - Development of an intermediate, nanoparticle-based product platform for individualized medication. [2018]

10. Poland pubmed.ncbi.nlm.nih.gov

[The effect of fluorine substituent on radiochemical stability of some steroid and azole derivatives]. [2016]