Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02200276
Other study ID # NA_00092365
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date June 2026

Study information

Verified date March 2024
Source Johns Hopkins University
Contact Engle Abrams
Phone 410-550-2061
Email eabrams3@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1025
Est. completion date June 2026
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Adults over age 75 years Exclusion Criteria: - 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)

Study Design


Intervention

Biological:
Influenza


Locations

Country Name City State
United States Johns Hopkins University; JHAAC 5501 Hopkins Bayview Circle, 1B84 Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Effectiveness of High Dose TIV Immunization To assess clinical effectiveness of High Dose TIV immunization in real world geriatric population over age 75 through post-vaccination influenza detection At the end of the study, 5th year
Other Influence of Frailty and Chronic CMV Infection on Vaccine-Induced Influenza Strain-Specific Antibody Titers and T-Cell Responses To assess potential interaction between chronic CMV infection as defined above and frailty in their impact on antibody and T-cell responses to as well as clinical protection of High Dose TIV immunization in the study population. At the end of the study, 5th year
Primary 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. At the end of each flu season for the next 4 years
Secondary Immune Responses to High Dose TIV Immunization At the end of the study-5th year
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A