Influenza
Conditions
Keywords
Influenza, Immunogenicity
Brief 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®). 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 \[28 days after acute visit if lab-confirmed positive for influenza\]).
Interventions
BIOLOGICALFlucelvax® (ccIIV3)
Participants will receive Flucelvax® (ccIIV3)
BIOLOGICALFlublok® (RIV3)
Participants will receive Flublok® (RIV3)
Sponsors
Duke University
Centers for Disease Control and Prevention
Arizona State University
University Hospitals Cleveland Medical Center
University of Pittsburgh
Washington University School of Medicine
VA Medical Center-Cleveland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 18-64 years that have not received the current season's influenza vaccine 2. English literate 3. Email or text message capability for weekly follow-up 4. Intention of receiving influenza vaccine based on ACIP-CDC guidelines 5. Willing to provide written/electronic informed consent 6. Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits
Exclusion criteria
1. Receipt of the current season's influenza vaccine (receipt after July 1, 2024) 2. History of severe allergic reaction after a previous dose of any influenza vaccine or to an influenza vaccine component 3. Receipt of any licensed or investigational live vaccine within 6 weeks or non-live vaccine within 2 weeks prior to enrollment in this study or planning receipt of any vaccines between visits 1 and 2 of the study (approximately within 4 weeks after the receipt of study-administered vaccine) 4. History of Guillain-Barré syndrome 5. Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 7. 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 Temporary Delay Criteria (Visit 1) 1\. History of febrile illness (\> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With a Seroprotective HAI Titer (≥1:40) | Visit 2 (Days 28-42, Post-vaccination) | The percent of participants with a seroprotective antibody titer (≥1:40) for each influenza vaccine antigen was determined. Cell-grown A(H1N1)pdm09 and B/Victoria were measured by hemagglutination inhibition (HAI), while A(H3N2) titers were measured by microneutralization. |
| The Geometric Mean Titer (GMT) of HAI Antibody | Up to Visit 2 (Days 28-42, Post-vaccination) | The geometric mean antibody titer (GMT) for each influenza vaccine antigen in the 2024-2025 influenza season. GMTs were calculated as the anti-log of the mean of log-transformed titers. Cell-grown A(H1N1)pdm09 and B/Victoria were assessed by hemagglutination inhibition (HAI), whereas A(H3N2) was assessed by microneutralization. |
| Percent of Participants Demonstrating Seroconversion From Baseline | Day 29 post-vaccination assessment (Visit 2; scheduled for Day 29 with an allowable window of Days 28-42 post-vaccination) | The percent of participants in each vaccination group demonstrating seroconversion from Baseline at Day 29 (defined as a titer ≥1:40 at Day 29 if the baseline titer is \<1:10, or a ≥4-fold rise in titer at Day 29 if the baseline titer is ≥1:10) for each vaccine antigen. Viruses tested were cell-grown A(H1N1)pdm09 and B/Victoria using hemagglutination inhibition (HAI), and A(H3N2) using microneutralization. |
| Geometric Mean Fold Rise (GMFR) in HAI Titer From Baseline | Day 29 post-vaccination assessment (Visit 2; scheduled for Day 29 with an allowable window of Days 28-42 post-vaccination) | The geometric mean fold rise (GMFR) in antibody titers from Baseline to Day 29 for each influenza vaccine antigen. Cell-grown A(H1N1)pdm09 and B/Victoria were assessed using hemagglutination inhibition (HAI), whereas A(H3N2) was assessed using microneutralization. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmmanuel B Walter, MD, MPH
Duke University
Participant flow
Pre-assignment details
7 participants were not randomized to a vaccine group; 2 due to protocol violations and 5 were considered screen fails.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38 years |
| Age, Customized 18-49 years | 445 Participants |
| Age, Customized 50-64 years | 154 Participants |
| Enrollment Site Arizona State | 69 Participants |
| Enrollment Site Cleveland VA | 12 Participants |
| Enrollment Site UH Hospital | 142 Participants |
| Enrollment Site University of Pittsburgh | 99 Participants |
| Enrollment Site Valleywise | 45 Participants |
| Enrollment Site Washington University | 75 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 37 Participants |
| Race/Ethnicity, Customized Black or African American | 36 Participants |
| Race/Ethnicity, Customized Hispanic | 74 Participants |
| Race/Ethnicity, Customized Middle Eastern or North African | 0 Participants |
| Race/Ethnicity, Customized Multiple Races | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 386 Participants |
| Sex/Gender, Customized Female | 206 Participants |
| Sex/Gender, Customized Male | 183 Participants |
| Sex/Gender, Customized Unknown | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 301 | 0 / 298 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 3 / 301 | 0 / 298 |
Outcome results
None listed