This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
This study is a prospective, randomized comparative immunogenicity study in an enrolled cohort. During this study, eligible participants will be randomly assigned to receive an approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus) and an approved mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart. Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza season. Demographic and health data (including influenza and COVID-19 vaccination and infection history) will be collected upon enrollment. Enrolled participants will be randomized to one of the following interventions (2:1:1) (i) concomitant administration of the mRNA COVID-19 vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus); (ii)sequential administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 1 (day 0) and the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii) sequential administration of the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 2 (day 28). Participants will not be blinded to vaccine group. Whole blood samples to isolate sera for immune assays will be collected prior to vaccination administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56; post-vaccination 2) and Visit 4 (day180; end of local flu circulation). Blood samples to isolate PBMC and plasma will be collected from a subset of 250 participants (200 adults and 50 children). If participants exhibit ARI during the study period, the participants may be asked to present for collection of a nasal swab for viral testing for acute influenza or SARS-CoV-2 infection (within 10 days after symptom onset), and blood specimen to isolate sera for immune assays. For participants with confirmed acute infection, the participants may be asked to present for collection of a convalescent-phase blood specimen approximately 28 days after acute visit for isolation of sera, PBMC and plasma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
455
Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.
mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, United States
ASU Biodesign Institute
Tempe, Arizona, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Washington University IDCRU
Percentage of Participants With HAI Seroconversion
Number of participants with a seroconversion HAI Titer ≥1:40 at Day 29 if Day 1 titer is \<1:10 or a four-fold rise at Day 29 if Day 1 titer is ≥1:10 for each ccIIV4 antigen in the 2023-2024 influenza season.
Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
Percentage of Participants With HAI Seroprotection
Number of participants with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each ccIIV4 antigen in the 2023-2024 influenza season.
Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Titer
The geometric mean HAI titer (GMT) for each ccIIV4 antigen in the 2023-2024 influenza season. GMTs were derived by using the anti-log of the mean of the log transformed titers.
Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Fold Rise (GMFR)
GMFRs and 95% confidence intervals were calculated using a t-distribution on log 2-transformed titers.
Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
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St Louis, Missouri, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Department of Family Medicine, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States