Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

Health Sciences North Research Institute85 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Elderly Immune System

Interventions

Flu VaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) \-

Locations (2)

Center on Aging, UConn Health

Farmington, Connecticut, United States

Health Sciences North Research Institute

Greater Sudbury, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: five years

Data from ClinicalTrials.gov

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