Immune Response, Safety
Conditions
Brief summary
The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
Detailed description
This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later * immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization. * safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.
Interventions
BIOLOGICALbivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine
The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
BIOLOGICALquadrivalent influenza vaccine
The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
Sponsors
Korea University Guro Hospital
Catholic Kwandong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
prospective, non-randomized clinical cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine * Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination
Exclusion criteria
* Individuals with a contraindication to any of the vaccine compounds were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups | at 28 days after booster dose | seroconversion rate of anti-SARS-CoV-2 S IgG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| geometric mean titer against SARS-CoV-2 | at 28 days after booster dose | geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody) |
| seroconversion rate of four influenza strains | at 28 days after immunization | seroconversion rate of four influenza strains |
| seroconversion rate of neutralizing antibody against SARS-CoV-2 | at 28 days after booster dose | seroconversion rate of neutralizing antibody against wild type, Omicron BA.5 |
| geometric mean titer against four influenza strain | at 28 days after immunization | geometric mean titer against four influenza strain |
| The incidence rate of adverse events (AEs) | within 28 days | The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs |
| seropositive rate of four influenza strains | at 28 days after immunization | seropositive rate of four influenza strains |
Countries
South Korea
Outcome results
None listed