Elderly Immune System
Conditions
Keywords
Influenza Vaccine
Brief summary
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
Interventions
BIOLOGICALFlu Vaccine
Sponsors
UConn Health
Health Sciences North Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent provided by the participant 2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old 3. Willing to receive influenza vaccination 4. Older cohort has received their influenza vaccine for the previous influenza season \-
Exclusion criteria
1. Immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily) 2. Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination 3. Participant has received a community available influenza vaccine for the approaching influenza season 4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Influenza Cases | five years | Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (\> 99°F or 37.3°C orally or 100°F rectally) \[41\]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season. |
Countries
Canada, United States
Outcome results
None listed