Immunogenicity of Influenza Vaccinations
NCT Number: NCT06518577
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Influenza
Interventions: BIOLOGICAL: Flucelvax (ccIIV4)|BIOLOGICAL: Flublok (RIV) or Fluzone (IIV)
Sponsor: Duke University
Collaborators: Centers for Disease Control and Prevention|Arizona State University|University Hospitals Cleveland Medical Center|University of Pittsburgh|Washington University School of Medicine|VA Northeast Ohio Health Care
Sex: ALL
Age: ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-15
Completion Date: 2025-05-30
Locations: Valleywise Health Comprehensive Health Center, Phoenix, Arizona, 85008, United States|ASU Biodesign Institute, Tempe, Arizona, 85281, United States|Centers for Disease Control and Prevention, Atlanta, Georgia, 30333, United States|Washington University IDCRU, Saint Louis, Missouri, 63110, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|VA Northeast Ohio Healthcare System (VANEOHS), Cleveland, Ohio, 44106, United States|Department of Family Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, 15260, United States

Summary:
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 \[28 days after acute visit if lab-confirmed positive for influenza\]).

Primary Outcome Measures: 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, Baseline, Day 29|The geometric mean titer (GMT) of HAI antibody, The geometric mean titer (GMT) of HAI antibody for each influenza vaccine antigen, 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, 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, Day 29