This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses. Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute \[\<10 days after symptom onset\] and convalescent \[28 days after acute visit if lab-confirmed positive for influenza\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
605
Participants will receive Flucelvax (ccIIV4)
Participants will receive Flublok (RIV) or Fluzone (IIV)
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, United States
ASU Biodesign Institute
Tempe, Arizona, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Washington University IDCRU
St Louis, Missouri, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland, Ohio, United States
Department of Family Medicine, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Participants with a seroprotective HAI titer (≥1:40)
The number (percent) of participants with a seroprotective HAI titer (≥1:40) for each influenza vaccine antigen
Time frame: Baseline, Day 29
The geometric mean titer (GMT) of HAI antibody
The geometric mean titer (GMT) of HAI antibody for each influenza vaccine antigen
Time frame: Baseline, Day 29
Number of participants demonstrating seroconversion from baseline
The number (percent) of participants in each vaccination group demonstrating seroconversion from Baseline at Day 29 (a titer ≥1:40 at Day 29 if the baseline titer is \<1:10 or a four-fold rise in titer at Day 29 if the baseline titer is \>1:10) as assessed by HAI titer for each vaccine antigen
Time frame: Day 29
Geometric mean fold rise (GMFR) in HAI titer from baseline
The geometric mean fold rise (GMFR) in HAI titer from Baseline to Day 29 across HAI titers for each influenza vaccine antigen
Time frame: Day 29
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