Flu Vaccines for Influenza

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byEmmanuel B Walter, MD, MPH

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals who want to help test the effectiveness of different flu vaccines: Flucelvax, Flublok, or Fluzone. Participants should be willing to provide blood and saliva samples over several months and report any symptoms of influenza-like illness.

Inclusion Criteria

Willing to provide written/electronic informed consent

I am between 18 and 64 years old and haven't had this season's flu shot.

I plan to get the flu vaccine as recommended.

See 3 more

Exclusion Criteria

Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives

I have had Guillain-Barré syndrome in the past.

I haven't had live vaccines in 6 weeks or non-live vaccines in 2 weeks before joining this study.

See 4 more

Treatment Details

Interventions

Flublok (Cancer Vaccine)
Flucelvax (Cancer Vaccine)
Fluzone (Cancer Vaccine)

Trial OverviewThe study compares three approved flu vaccines by measuring immune responses in participants. It involves random assignment to one vaccine type, regular health surveys, and collection of blood/saliva at specific times to assess immunogenicity.

Participant Groups

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.