Elderly Immune System Clinical Trial
Official title:
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
| Verified date | February 2018 |
| Source | Health Sciences North Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 85 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Health Sciences North Research Institute | Sudbury | Ontario |
| United States | Center on Aging, UConn Health | Farmington | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Health Sciences North Research Institute | UConn Health |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Influenza Cases | 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. | five years |