Contaminant Injected, COVID-19, Influenza, Vaccine Reaction
Conditions
Keywords
COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration
Brief summary
The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
Detailed description
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later * immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination). * 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
BIOLOGICALOmicron-containing COVID-19 vaccine
The COVID-19 vaccine approved for use in the 2023-2024 season
BIOLOGICALinfluenza vaccine
inactivated vaccine containing 15μg hemagglutinin antigen/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season
Sponsors
Korea University Guro Hospital
Catholic Kwandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
prospective, randomized clinical cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* who agreed to receive both booster COVID-19 vaccine and influenza vaccine * individuals who have received the COVID-19 vaccine three or more times and have passed at least 3 months after the last vaccination * individuals with a history of a single SARS-CoV-2 infection during the Omicron outbreak period (January 2022-February 2023)
Exclusion criteria
* individuals with a contraindication to any of the vaccine compounds * individuals with a history of influenza infection within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination | geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| geometric mean titer against four influenza strain | at 28 days and 7 months after influenza vaccination | geometric mean titer against four influenza strain |
| vaccine-induced B-cell responses | at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination | vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines |
| vaccine-induced CD4+ T cell responses | at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination | vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines |
| The incidence rate of adverse events | within 28 days | The incidence rate of adverse events within 7 days, 28 days, and serious adverse events |
Countries
South Korea
Outcome results
None listed