Clinical trial NCT06091410: Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines
Official title: Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: COVID-19
Influenza
Vaccine Reaction
Contaminant Injected
Keywords: COVID-19 vaccine
influenza vaccine
immunogenicity
co-administration
Lead sponsor: Catholic Kwandong University
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
First posted: 2023-10-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized clinical cohort study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
timeFrame: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
Secondary outcomes:
measure: geometric mean titer against four influenza strain
timeFrame: at 28 days and 7 months after influenza vaccination
measure: vaccine-induced B-cell responses
timeFrame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
measure: vaccine-induced CD4+ T cell responses
timeFrame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
measure: The incidence rate of adverse events
timeFrame: within 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
city: Incheon
country: Korea, Republic of
facility: International St. Mary's hospital
state: Seo-gu
Study officials:
affiliation: International St. Mary's Hospital
name: Min Joo Choi
role: PRINCIPAL_INVESTIGATOR
References: