Immunogenicity of Influenza Vaccinations

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

Conditions

• Influenza

Interventions

BIOLOGICAL

Flucelvax (ccIIV4)

Participants will receive Flucelvax (ccIIV4)

BIOLOGICAL

Flublok (RIV) or Fluzone (IIV)

Participants will receive Flublok (RIV) or Fluzone (IIV)

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Arizona State University

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• VA Medical Center-Cleveland

  collaborator UNKNOWN

• Duke University

  lead OTHER

Principal Investigators

• Emmanuel B Walter, MD, MPH · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-09

Primary Completion

2024-12-09

Completion

2025-06-04

FDA Drug

Yes

Countries

• United States

Study Locations