Flu Vaccines for Influenza
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not receive any live vaccines within 6 weeks or non-live vaccines within 2 weeks before joining the study.
What data supports the effectiveness of the treatment Flublok, Flucelvax, Flucelvax Quadrivalent, Flucelvax Tetra, Fluzone, Fluzone High-Dose, Fluzone High-Dose Quadrivalent, Influenza Virus Vaccine?
Research shows that high-dose versions of the Fluzone vaccine are effective in older adults, and Flucelvax Tetra has been recommended for healthcare workers due to its effectiveness against certain flu strains. Additionally, FluBlok is being tested for its ability to prevent flu infections, showing promise in ongoing trials.12345
Is the flu vaccine safe for humans?
The flu vaccines, including Flublok, Flucelvax, and Fluzone, have been studied for safety in various age groups. Most reported side effects are mild and not serious, such as local reactions at the injection site. Serious side effects are rare, and ongoing safety monitoring supports their general safety in humans.25678
How is the Fluzone High-Dose Quadrivalent vaccine different from other flu vaccines?
Fluzone High-Dose Quadrivalent is unique because it contains a higher amount of hemagglutinin, a protein that helps the body build immunity, compared to standard flu vaccines. This high-dose formulation is specifically designed to provide better protection for older adults, who may have weaker immune responses.124910
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 \[28 days after acute visit if lab-confirmed positive for influenza\]).
Research Team
Emmanuel B Walter, MD, MPH
Principal Investigator
Duke University
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an influenza vaccine (Flucelvax, Flublok, or Fluzone) and provide blood samples for biomarker measurement
Follow-up
Participants are monitored for immune response and influenza-like illness symptoms, with weekly electronic surveys and potential additional blood draws
Treatment Details
Interventions
- Flublok
- Flucelvax
- Fluzone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
VA Medical Center-Cleveland
Collaborator
University of Pittsburgh
Collaborator
Washington University School of Medicine
Collaborator
Arizona State University
Collaborator
VA Northeast Ohio Health Care
Collaborator
Centers for Disease Control and Prevention
Collaborator
University Hospitals Cleveland Medical Center
Collaborator