Influenza Immunization in Adults Over Age 75

NCT02200276 | Recruiting

• 1 other identifier: NA_00092365
• Study Type: interventional
• Target: 1,025
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunization; Older Adults; Over Age 75; Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Immune Responses to High Dose TIV Immunization

  At the end of the study-5th year

Other Outcomes (2)

• Effectiveness of High Dose TIV Immunization

  At the end of the study, 5th year

• Influence of Frailty and Chronic CMV Infection on Vaccine-Induced Influenza Strain-Specific Antibody Titers and T-Cell Responses

  At the end of the study, 5th year

Study Arms (1)

Influenza Immunization

OTHER

Influenza immunization in adults over age 75

Biological: Influenza

Interventions

Influenza BIOLOGICAL

Influenza Immunization

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults over age 75 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

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

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Sean Leng

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trudymae Agboka, M.S. Biology

CONTACT

410-550-5744; tagboka1@jhmi.edu

Cherise Young

CONTACT

410-550-2061; cyoun123@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 25, 2014
• Study Start: March 1, 2014
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)