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InfluenzaNCT02200276

Influenza Immunization in Adults Over Age 75

A study testing Influenza in people with Influenza and Immunization, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Immunization, Older Adults
What is being tested?
Influenza
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,025 participants
Where
1 siteUnited States
Study dates
Mar 2014to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Adults over age 75 years

Who cannot join

  • Allergies to egg or vaccine
  • Active malignancies
  • On radiation or chemotherapy
  • Active systemic inflammatory diseases including rheumatoid arthritis, Crohn's disease, and ulcerative colitis
  • Acute exacerbation of chronic cardiopulmonary conditions including decompensated CHF or COPD
  • Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate).
  • Lacking the capacity to consent (individuals who do not understand what Flu shot is or need someone else to decide if s/he should get the Flu shot)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Trudymae Agboka, M.S. Biology contact

410-550-5744

tagboka1@jhmi.edu

Cherise Young contact

410-550-2061

cyoun123@jh.edu

United States1 site, 1 recruiting
  • Johns Hopkins University; JHAAC 5501 Hopkins Bayview Circle, 1B84

    Baltimore, Maryland, 21224

    Cherise Young, 410-550-2061, cyoun123@jh.edu

    Trudymae Agboka, M.S. Biology, 410-550-6763, Tagboka1@jhmi.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Seasonal influenza causes significant morbidity and mortality and is the fourth leading cause of death for older Americans. Annual immunization with a trivalent inactivated influenza vaccine (TIV) is recommended for all adults 50 years and older. However, despite improved vaccination coverage in older adults over time, influenza-related mortality has actually increased. While many TIV studies indicate its benefit for older adults as a whole, these studies lacked representation of the older and frail subset of the elderly who suffer over three-quarters of influenza-related mortality. Our pilot study funded by a Beeson K23 award showed significant vaccine failures in both antibody response to TIV and clinical protection in the frail elderly. Our preliminary data also suggest that chronic cytomegalovirus (CMV) infection as defined by the presence of CMV viral DNA in peripheral monocytes using a highly sensitive and specific nested PCR-based assay developed in our laboratory, rather than anti-CMV IgG serology, is associated with poor antibody and T-cell responses to TIV immunization as well as poor clinical protection. This is likely because anti-CMV IgG serology, the conventional diagnostic measure for chronic CMV infection, is a crude measure that merely indicates prior exposure to CMV and does not distinguish chronic (persistent) from past (resolved) infections. Mechanistically, precipitous immune functional decline has been observed in those over 75 and chronic CMV infection may contribute significantly to age-related immune senescent remodeling, termed immunosenescence. In order to improve our assessment of the effectiveness of TIV immunization and understanding of risk factors and underlying immune mechanisms that determine vaccine failure in adults over age 75, the frail, oldest old adult subset, this study is designed to conduct prospective, 4-year TIV immunization and post-vaccination influenza surveillance in adults over 75 years. We will first assess chronic CMV infection defined by detectable CMV DNA in peripheral blood monocytes and frailty status of the study participants and administer the Fluzone High-Dose TIV vaccine. Influenza-like illness (ILI) cases will be identified through post-vaccination influenza surveillance as previously done in the Beeson project and respiratory specimens obtained from ILI cases will be tested using the cutting edge PCR-based IBIS assay which can accurately subtype influenza and other respiratory viruses in the laboratory of Dr. Charlotte Gaydos in Division of Infectious Disease, a co-investigator of this project. Strain-specific antibody responses to TIV immunization will be measured by the standard hemogglutination inhibition (HI) assay. We will also evaluate T-cell responses to influenza viruses at baseline and after TIV immunization. Taken together, these studies will provide more accurate assessment of the clinical effectiveness of TIV immunization in real world geriatric population over age 75 and its underlying humoral and cell-mediated immune mechanisms. Moreover, we investigate the role of chronic CMV infection as defined by the presence of CMV viral DNA in peripheral monocytes as a risk factor for vaccine failure in the elderly over age 75. Because this oldest old subset is growing most rapidly in numbers and is at greatest risk for influenza-related morbidity and mortality. The long-term goal of this research is to strengthen immune protection against influenza for vulnerable older Americans through more effective and targeted immunization strategies as well as possibly through prevention and mitigation of chronic CMV infection.

Being tested
Influenza
Keywords
Influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfluenzaBiological

Study groups in NCT02200276
Study groupRoleWhat they receive
Influenza ImmunizationOtherInfluenza immunization in adults over age 75
Receives: Biological: Influenza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of CMV Viral DNA in Peripheral Blood Monocytes

    To assess the role of chronic CMV infection as defined by presence of CMV viral DNA in peripheral monocytes as a risk factor for vaccine failure in this oldest old subset.

    Measured: At the end of each flu season for the next 4 years

Secondary outcomes (1)
  1. Immune Responses to High Dose TIV Immunization

    Measured: At the end of the study-5th year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study startMar 2014
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,025 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02200276
Sponsor's protocol ID
NA_00092365
Status last verified
Mar 2026
First submitted
11 Jul 2014
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Influenza in people with Influenza and Immunization, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trudymae Agboka, M.S. Biology (410-550-5744, tagboka1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of CMV Viral DNA in Peripheral Blood Monocytes (time frame: At the end of each flu season for the next 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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