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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Vaccine Reaction; Influenza; Contaminant Injected
• Intervention / Treatment: Biological: Omicron-containing COVID-19 vaccine; Biological: influenza vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Guro-gu
    • Seoul, Guro-gu, Korea, Republic of, 08308
      • Korea University Guro Hospital
  • Seo-gu
    • Incheon, Seo-gu, Korea, Republic of, 22711
      • International St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 hemagglutinin antigen/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 hemagglutinin antigen/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)	geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)	at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of adverse events	The incidence rate of adverse events within 7 days, 28 days, and serious adverse events	within 28 days
geometric mean titer against four influenza strain	geometric mean titer against four influenza strain	at 28 days and 7 months after influenza vaccination
vaccine-induced B-cell responses	vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines	at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
vaccine-induced CD4+ T cell responses	vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines	at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination

Collaborators and Investigators

• Sponsor: Catholic Kwandong University
• Collaborators: Korea University Guro Hospital
• Investigators: Principal Investigator: Min Joo Choi, International St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): February 25, 2025
• Study Completion (Estimated): June 25, 2025

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: immunogenicity; influenza vaccine; co-administration; COVID-19 vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Orthomyxoviridae Infections; COVID-19; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IS23OIME0055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes