Flu Shot for Elderly Individuals

Recruiting in Palo Alto (17 mi)

Overseen by Sean Leng

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Oral steroids, Immune modulators

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

No Placebo Group

Approved in 9 Jurisdictions

Trial Summary

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.

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.

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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.

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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.

Trial 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

Participant Groups

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.

Group I: Influenza Immunization Experimental Treatment 1 Intervention

Influenza immunization in adults over age 75

Influenza is already approved in United States, United States, United States, United States, United States, United States, European Union, European Union, 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University; JHAAC 5501 Hopkins Bayview Circle, 1B84 Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

References

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

Older Adults' Preferences Regarding Firearm Locking Device Use: Results of a National Survey. [2023] Use of firearm locking devices may reduce the risk of suicide and injury among older adults. This study describes older adults' preferences when choosing a firearm locking device.

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

Firearm-related experiences and perceptions among United States male veterans: A qualitative interview study. [2023] Male veterans ages 55-74 comprise a disproportionate number of suicide deaths among United States veterans, for whom a majority of suicides are firearm-related. Little is known about the firearm-related experiences and beliefs of veterans, which could be informative for firearm-related lethal means safety interventions. The aim of this qualitative study was to identify themes relevant to developing such interventions among older male veterans.

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] Firearms are a leading cause of injury mortality across the lifespan, with elevated risks for older adult populations. To inform prevention efforts, we conducted a probability-based web survey (12/1/2019-12/23/2019) of 2048 older adults (age 50-80) to characterize national estimates of firearm ownership, safety practices, and attitudes about health screening, counseling, and policy initiatives. Among older U.S. adults, 26.7% [95%CI = 24.8%-28.8%] report owning one or more firearms. The primary motivation for ownership was protection (69.5%), with 90.4% highlighting a fear of criminal assault. 39.4% of firearm owners reported regularly storing firearm(s) unloaded and locked, with 24.2% regularly storing at least one loaded and unlocked. While most firearm owners found healthcare screening (69.2% [95%CI: 64.9-73.1]) and safety counseling (63.2% [95%CI = 58.8-67.3]) acceptable, only 3.7% of older adults reported being asked about firearm safety by a healthcare provider in the past year. Among firearm owners, there was support for state-level policy interventions, including allowing family/police to petition courts to restrict access when someone is a danger to self/others (78.9% [95%CI = 75.1-82.3]), comprehensive background checks (85.0% [95%CI = 81.5-87.9]), restricting access/ownership under domestic violence restraining orders (88.1%; 95%CI = 84.9-90.7], and removing firearms from older adults with dementia/confusion (80.6%; 95%CI = 76.8-84.0]. Healthcare and policy-level interventions maintained higher support among non-owners than owners (p's

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

Injury patterns related to use of less-lethal weapons during a period of civil unrest. [2019] This case series documents injury patterns related to beanbag and other less-lethal (LL) weapons during a period of civil unrest in a major U.S. city. A retrospective review of injuries related to LL weapons usage presenting to an urban Emergency Department (ED) from April 10, 2001 to April 18, 2001 was performed. Patients under 18 years of age and those without signed consent to treat were excluded. Twenty-seven patients were identified. Two were excluded due to lack of signed consent for treatment. Mean age was 28.4 +/- 11.7 years; 76% of patients were male. Significant morbidity was found in 7 (28%) cases with no fatalities. Three (12%) individuals, with the diagnoses of pulmonary contusion, liver laceration, and Achilles tendon rupture, required admission. Two (8%) individuals had delayed complications of pneumonia and post-concussive syndrome. Reports of injury patterns associated with beanbag munitions in the medical literature are limited. Physicians should be aware of the injuries and delayed sequelae associated with their use.

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

Eye injuries in the elderly from consumer products in the United States: 2001-2007. [2021] To quantify and characterize eye injuries related to consumer products in elderly patients (≥ 65) treated in United States (US) hospital emergency departments (EDs) in 2001-2007.

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] Persons aged >or=65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups, and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults. On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone. Fluzone High-Dose is licensed as a single dose for use among persons aged >or=65 years and will be available beginning with the 2010-11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines. This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.

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

MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. [2013] Influenza is a highly contagious respiratory disease associated with substantial morbidity and mortality in vulnerable populations, especially the elderly. Influenza viruses are unique in that they undergo small mutations and antigenic variation in their hemagglutinin and neuraminidase genes. Owing to the senescence of the immune system, the ability to mount novel immune responses may be particularly compromised in older people. Fluad (Novartis Vaccines), an MF59-adjuvanted subunit influenza vaccine, was formulated in order to achieve greater immunogenicity in those groups who need a higher protection than that brought about by conventional vaccines. This article summarizes the main characteristics of MF59-adjuvanted subunit influenza vaccine, the clinical effectiveness data that have been generated in recent years and future developments.

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] The age-related weakening of the immune system makes elderly subjects less responsive to influenza vaccination. In the last years, two "enhanced vaccines" were licensed for individuals aged ≥65 years, one being a subunit vaccine (Fluad®) containing the MF59 adjuvant administered intramuscularly (IM-MF59) and the other one a split non-adjuvanted vaccine administered intradermally (Intanza® 15mcg) (ID). In the present study, we evaluated and compared the antibody responses against the three vaccine antigens and heterovariant A(H3N2) circulating viruses induced by IM-MF59 and ID influenza vaccines in 80 elderly institutionalized volunteers (40 per group) during the Winter season 2011-2012.

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] The safety and tolerability of Flublok(®), a purified recombinant hemagglutinin seasonal influenza vaccine, was compared to AFLURIA(®) in a randomized, blinded clinical trial in adults ≥ 50 years of age with attention to hypersensitivity reactions.

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

Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. [2021] Advanced age is associated with an increase in morbidity and mortality from influenza. Immunization is the best option to protect individuals against influenza and its complications. Older people are less likely than their younger counterparts to mount an appropriate immune response to influenza vaccines. The adjuvanted inactivated influenza vaccine quadrivalent (aIIV4) is designed to elicit a more robust immune response in older people compared with traditional inactivated influenza vaccines. The aIIV4 is indicated for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine and is licensed by the Food and Drug Administration for use in persons 65 years of age and older. The aIIV4 should be administered by intramuscular injection. Like other influenza vaccines, aIIV4 carries a warning regarding the occurrence of Guillain-Barré syndrome. The most common adverse reactions associated with aIIV4 are injection site pain, fatigue, headache, arthralgia, and myalgia.