Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines

Sponsor

Catholic Kwandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06091410

Collaborator

Korea University Guro Hospital (Other)

Enrollment

Locations

Arms

2.4

Anticipated Duration (Months)

Patients Per Site

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Influenza Vaccine Reaction Contaminant Injected	Biological: Omicron-containing COVID-19 vaccine Biological: influenza vaccine	Phase 4

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 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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized clinical cohort studyprospective, randomized clinical cohort study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.

Actual Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Dec 8, 2023

Anticipated Study Completion Date :

Dec 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C group concomitant administration of COVID-19 booster and quadrivalent influenza vaccination	Biological: Omicron-containing COVID-19 vaccine The COVID-19 vaccine approved for use in the 2023-2024 season Biological: influenza vaccine inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season
Placebo Comparator: S group (COVID-19 vaccine only) separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later	Biological: Omicron-containing COVID-19 vaccine The COVID-19 vaccine approved for use in the 2023-2024 season
Placebo Comparator: S group (influenza vaccine only) separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later	Biological: influenza vaccine inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season

Arm

Intervention/Treatment

Experimental: C group

concomitant administration of COVID-19 booster and quadrivalent influenza vaccination

Biological: Omicron-containing COVID-19 vaccine

The COVID-19 vaccine approved for use in the 2023-2024 season

Biological: influenza vaccine

inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season

Placebo Comparator: S group (COVID-19 vaccine only)

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Biological: Omicron-containing COVID-19 vaccine

The COVID-19 vaccine approved for use in the 2023-2024 season

Placebo Comparator: S group (influenza vaccine only)

separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later

Biological: influenza vaccine

inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season

Outcome Measures

Primary Outcome Measures

geometric mean titer against SARS-CoV-2 [at 7 and 28 days after COVID-19 vaccination]
geometric mean titer against SARS-CoV-2 (Anti-S IgG, Neutralizing antibody)

Secondary Outcome Measures

geometric mean titer against four influenza strain [at 28 days after influenza vaccination]
geometric mean titer against four influenza strain
vaccine-induced B-cell responses [at 7 and 28 days 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 and 28 days 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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-Feburary 2023)