Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines

Sponsor

Catholic Kwandong University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05970887

Collaborator

Korea University Guro Hospital (Other)

154

Enrollment

Location

Arms

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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 healthcare workers (HCWs) during 2022-23 season.

Condition or Disease	Intervention/Treatment	Phase
Immune Response Safety	Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine Biological: quadrivalent influenza vaccine	Phase 4

Detailed Description

This is a single-center, prospective, non-randomized clinical cohort study. 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, non-randomized clinical cohort studyprospective, non-randomized clinical cohort study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines Among Healthcare Workers : a Single Center Prospective Study

Actual Study Start Date :

Oct 12, 2022

Actual Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Oct 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: C group Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination	Biological: bivalent 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. Biological: quadrivalent 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
Placebo Comparator: S group (COVID-19 vaccine only) sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later	Biological: bivalent 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.
Placebo Comparator: S group (influenza vaccine only) sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later	Biological: quadrivalent 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

Arm

Intervention/Treatment

Experimental: C group

Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination

Biological: bivalent 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.

Biological: quadrivalent 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

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

sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine

Placebo Comparator: S group (influenza vaccine only)

sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later

Biological: quadrivalent 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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
seropositive rate of four influenza strains [at 28 days after immunization]
seropositive rate of four influenza strains
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

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International St. Mary's hospital	Incheon	Seo-gu	Korea, Republic of	22711

Sponsors and Collaborators

Catholic Kwandong University
Korea University Guro Hospital

Investigators

Principal Investigator: Min Joo Choi, Doctor, International St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Min Joo Choi, Assistant Professor, Catholic Kwandong University

ClinicalTrials.gov Identifier:

NCT05970887

Other Study ID Numbers:

IS22OISE0060

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Vaccines

Study Results

No Results Posted as of Aug 1, 2023