Flu Shot for Elderly Individuals

Overseen By Janna Shapiro

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Oral steroids, Immune modulators

Disqualifiers: Egg allergy, Active malignancies, Inflammatory diseases, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

1025 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking oral steroids or immune-modulating drugs.

Is the flu shot safe for elderly individuals?

The flu shot, including versions like Fluzone, Fluad, Flublok, Flucelvax, Afluria, and FluMist, is generally considered safe for elderly individuals. It has been widely used and studied, showing a good safety profile in humans. ^{1 2 3 4 5}

How is the flu shot for elderly individuals different from other flu treatments?

The flu shot for elderly individuals, such as Fluad, is unique because it includes an MF59 adjuvant, which helps boost the immune response in older adults who typically have a weaker immune system. This makes it more effective in providing protection against the flu compared to standard vaccines. ^{6 7 8 9 10}

What is the purpose of this trial?

The immune system is the part of the body that protects against infection. The immune system often doesn't work as effectively as people get older. This research is being done to find out how the immune systems in older people who are over age 75 respond to influenza vaccine (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common virus infection in older persons affects the immune response in people older than 75 years of age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of influenza ("Flu") infections and is recommended every year for all persons 50 years and older. People who are older than 75 years of age are considered healthy or frail may join. A total of 1025 persons will be participating in this study. In order to determine if you are qualified for the study, we would ask you to answer a few questions over the phone that will take approximately 5 minutes. If you qualify and agree to proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are unable to come to Bayview, one of our staff can visit you at your home. During that visit we obtain consent, review your medical history, and measure your vital signs, walking speed and grip strength. We will also administer a few brief questionnaires and collect urine and blood samples. We will then give you the Influenza vaccine for free. 7 days post receiving your Influenza Vaccine we will collect a small blood sample for further immune system testing. also, you will be asked to complete a 12-question survey which will assess your symptoms over the past 7 days (post receiving the Influenza vaccine). Also 4 weeks post receiving your Influenza vaccine you will be asked to complete a third visit that will include follow up health questionnaires and an influenza symptoms assessment questionnaire and vital signs. A third blood draw will be collected (approximately 10 teaspoons) to measure immune responses to the influenza vaccine. In addition, you will receive your test result (CBC/w/Diff.) from visit #1. Throughout the influenza study season, we will call you once a week to ask about your general health and any Flu-like symptoms. These calls will be made throughout the Flu season which typically lasts through May. If you begin to have any influenza like symptoms at any time during the study, we ask that you call our office to report these symptoms so that we may perform vital signs, nasal swab to confirm influenza, and a fourth blood draw to look at the immune response and protection of influenza vaccine.

Research Team

Sean Leng

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over the age of 75, regardless of their health status. It's not suitable for those on cancer treatments, with egg or vaccine allergies, active cancers, inability to consent, acute heart/lung conditions exacerbations, or taking steroids/immune-modifying drugs.

Inclusion Criteria

I am over 75 years old.

Exclusion Criteria

I am currently undergoing radiation or chemotherapy.

I am currently taking oral steroids or drugs that affect my immune system.

You are allergic to eggs or vaccines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or at home)

Vaccination and Initial Monitoring

Participants receive the Influenza vaccine and initial monitoring including blood samples and surveys

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including weekly health calls and additional blood draws if symptoms occur

Flu season (up to 6 months)

Weekly calls, additional visits if symptoms occur

Long-term Surveillance

Annual assessment of vaccine effectiveness and chronic CMV infection impact over 4 years

4 years

Treatment Details

Interventions

• Influenza

Trial Overview The study tests how well people over 75 respond to the flu shot and if chronic CMV infection affects this response. Participants will receive a free flu shot and undergo health assessments including blood draws before and after vaccination.

Participant Groups

Group I: Influenza Immunization Experimental Treatment 1 Intervention

Influenza immunization in adults over age 75

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

Approved in United States as Fluzone for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as Fluad for:

• Prevention of influenza infections in individuals 65 years and older

Approved in United States as Flublok for:

• Prevention of influenza infections in individuals 18 years and older

Approved in United States as Flucelvax for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as Afluria for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as FluMist for:

• Prevention of influenza infections in individuals 2 through 49 years

Approved in European Union as Fluzone for:

• Prevention of influenza infections in individuals 6 months and older

Approved in European Union as Fluad for:

• Prevention of influenza infections in individuals 65 years and older

Approved in European Union as Flublok for:

• Prevention of influenza infections in individuals 18 years and older

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

A study of 2,152 US adult firearm owners found that older adults (≥65 years) prioritize speed and ease of access when selecting firearm locking devices, which are crucial for reducing the risk of suicide and injury.

Older males specifically prefer locking devices that allow firearms to remain loaded, indicating that their preferences may influence the effectiveness of firearm injury prevention strategies in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Preferences Regarding Firearm Locking Device Use: Results of a National Survey. Villarreal, RI., Stanley, IH., Anestis, MD., et al.[2023]

A qualitative study involving 17 male veterans aged 50-70 revealed that early firearm experiences, often facilitated by family, shape their beliefs about firearm safety and usage, highlighting the importance of social and familial contexts in firearm-related interventions.

Veterans expressed a strong belief in the need for firearm safety discussions, particularly emphasizing that not everyone should have access to firearms, which suggests that targeted interventions should consider their values and preferences for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Firearm-related experiences and perceptions among United States male veterans: A qualitative interview study. Simonetti, JA., Dorsey Holliman, B., Holiday, R., et al.[2023]

Approximately 26.7% of older adults (ages 50-80) in the U.S. own firearms, primarily for protection, but only 39.4% store them safely (unloaded and locked), highlighting a significant risk for injury mortality in this age group.

There is strong support among older firearm owners for policy interventions aimed at enhancing safety, such as comprehensive background checks and restricting access for individuals deemed a danger to themselves or others, indicating a potential pathway for improving firearm safety through healthcare and policy initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Firearm ownership, attitudes, and safe storage practices among a nationally representative sample of older U.S. adults age 50 to 80. Carter, PM., Losman, E., Roche, JS., et al.[2022]

In a review of 27 patients injured by less-lethal weapons during civil unrest, 28% experienced significant morbidity, highlighting the potential for serious injuries despite the non-lethal intent of these weapons.

Among the injuries documented, three patients required hospitalization for severe conditions, including pulmonary contusion and liver laceration, indicating that even less-lethal weapons can cause critical harm and necessitate medical awareness of possible complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury patterns related to use of less-lethal weapons during a period of civil unrest. Suyama, J., Panagos, PD., Sztajnkrycer, MD., et al.[2019]

An estimated 67,864 emergency department visits by elderly patients (≥ 65 years) for consumer product-related eye injuries occurred in the U.S. from 2001 to 2007, with a significant majority (64%) being male and 70% of incidents happening at home.

The most common causes of these injuries were chemicals (22%) and cutting tools/construction (21%), with a high proportion of preventable injuries associated with cutting tools (90%) and gardening (88%), indicating a need for improved safety measures in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye injuries in the elderly from consumer products in the United States: 2001-2007. Chen, AJ., Kim, JG., Linakis, JG., et al.[2021]

Fluzone High-Dose is an injectable influenza vaccine specifically designed for individuals aged 65 and older, containing a higher amount of hemagglutinin antigen to improve immune response compared to standard vaccines.

The FDA approved Fluzone High-Dose for this age group due to their increased risk of severe influenza outcomes, although the Advisory Committee on Immunization Practices did not express a preference for it over other vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

Fluad, an MF59-adjuvanted subunit influenza vaccine, is specifically designed to enhance immune responses in vulnerable populations, particularly the elderly, who may have weakened immune systems.

Clinical effectiveness data indicate that Fluad provides greater immunogenicity compared to conventional influenza vaccines, potentially offering better protection against the disease in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. Puig Barberà, J., González Vidal, D.[2013]

In a study involving 80 elderly volunteers, both the intramuscular MF59-adjuvanted vaccine (Fluad®) and the intradermal vaccine (Intanza®) effectively increased antibody responses against influenza strains A(H3N2) and A(H1N1) one month after vaccination.

The intradermal vaccine showed higher antibody responses against the B strain compared to the intramuscular vaccine, although both vaccines had lower responses against the B strain than the A strains. Both vaccines also provided positive responses against circulating drifted A(H3N2) viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibody responses to intradermal or intramuscular MF59-adjuvanted influenza vaccines as evaluated in elderly institutionalized volunteers during a season of partial mismatching between vaccine and circulating A(H3N2) strains. Camilloni, B., Basileo, M., Di Martino, A., et al.[2021]

In a clinical trial involving 2640 adults aged 50 and older, Flublok showed non-inferior safety compared to AFLURIA regarding hypersensitivity reactions, with only a slight difference in reported cases (0.15%).

Both vaccines had similar reactogenicity and overall adverse event profiles, indicating that Flublok is a safe alternative for seasonal influenza vaccination in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. Izikson, R., Leffell, DJ., Bock, SA., et al.[2022]

The adjuvanted inactivated influenza vaccine quadrivalent (aIIV4) is specifically designed to enhance the immune response in older adults (65 years and older), who typically have a weaker response to standard influenza vaccines.

While aIIV4 is effective in protecting against influenza, it does carry a warning for potential Guillain-Barré syndrome and common side effects include injection site pain, fatigue, headache, and muscle aches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. Barranco, D., Chahine, EB.[2021]

References

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

Older Adults' Preferences Regarding Firearm Locking Device Use: Results of a National Survey. [2023]

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

Firearm-related experiences and perceptions among United States male veterans: A qualitative interview study. [2023]

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

Firearm ownership, attitudes, and safe storage practices among a nationally representative sample of older U.S. adults age 50 to 80. [2022]

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

Injury patterns related to use of less-lethal weapons during a period of civil unrest. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Eye injuries in the elderly from consumer products in the United States: 2001-2007. [2021]

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

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

7. England pubmed.ncbi.nlm.nih.gov

MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. [2013]

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

Antibody responses to intradermal or intramuscular MF59-adjuvanted influenza vaccines as evaluated in elderly institutionalized volunteers during a season of partial mismatching between vaccine and circulating A(H3N2) strains. [2021]

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

Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. [2022]

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

Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. [2021]