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Cancer Vaccine

Flublok (RIV) or Fluzone (IIV) for Influenza

Phase 4
Waitlist Available
Led By Emmanuel B Walter, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Adults aged 18-64 years that have not received the current season's influenza vaccine
2. English literate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights

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

Eligible Conditions
  • Influenza

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric mean fold rise (GMFR) in HAI titer from baseline
Number of participants demonstrating seroconversion from baseline
Participants with a seroprotective HAI titer (≥1:40)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Flucelvax (ccIIV4)Experimental Treatment1 Intervention
Participants will receive Flucelvax (ccIIV4) at Visit 1.
Group II: Flublok (RIV) or Fluzone (IIV)Experimental Treatment1 Intervention
Participants will receive Flublok (RIV) or Fluzone (IIV) at Visit 1.

Find a Location

Who is running the clinical trial?

University of PittsburghOTHER
1,743 Previous Clinical Trials
16,341,017 Total Patients Enrolled
Washington University School of MedicineOTHER
1,963 Previous Clinical Trials
2,312,662 Total Patients Enrolled
Duke UniversityLead Sponsor
2,410 Previous Clinical Trials
3,062,064 Total Patients Enrolled
~400 spots leftby May 2025