Immunogenicity of COVID-19 Vaccine Co-administration with Influenza Vaccine in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Immune Response to SARS-CoV-2
• Interventions: Biological: Bivalent mRNA SARS-CoV-2 vaccine; Biological: Quardrivalent influenza vaccine

• Registration Number: NCT06831786
• Lead Sponsor: Prince of Songkla University

Brief Summary

This study, a pilot randomized controlled trial, single-blind (outcome assessor), evaluating the immune response (both humoral and cell-mediated) against SARS-CoV-2 and the safety of three different vaccine administration approaches: the SARS-CoV-2 mRNA vaccine alone, the influenza vaccine alone, and the co-administration of both vaccines.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Thai adults aged 18-60 years, who have vaccinated COVID-19 and influenza vaccine more than 6 months.
• The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 1-month follow-up of the study.
• Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization.
• The subject can provide with informed consent and sign informed consent form (ICF).

Exclusion Criteria

• Have history of influenza or COVID-19 infection within 6 months.
• Have the medical history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
• Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
• History of Guillain-Barré syndrome.
• Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months of after baseline period.
• Have infectious diseases, including HIV and SARS-CoV-2 infection or any symptom of common cold.
• Have history of SARS-CoV-2 infection less than 6 months.
• Having severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
• Have the history of urticaria 1 year before receiving the investigational vaccine.
• Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
• Having needle sickness.
• Have the history of immunosuppressive therapy, cytotoxic therapy, or systemic corticosteroids.
• Have received blood products within 4 months before injection of investigational vaccines.
• Under anti-tuberculosis treatment.
• Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social, or other conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalent mRNA BNT162b2	Bivalent mRNA SARS-CoV-2 vaccine	Administering a booster dose of the bivalent mRNA vaccine BNT162b2.
Quardrivalent influenza vaccine	Quardrivalent influenza vaccine	Administering a VaxigripTetra™
Co-administration	Bivalent mRNA SARS-CoV-2 vaccine	Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™
Co-administration	Quardrivalent influenza vaccine	Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™

Primary Outcome Measures

Name	Time	Method
Geometric mean ratio (GMR) of Interferon-gamma (IFN-γ) response against the SARS-CoV-2 virus at 4 weeks post-vaccination	4 weeks post vaccine administration	IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay. GMR between the experimental and comparator arms.
Geometric mean ratio (GMR) of IgG response against the SARS-CoV-2 virus at 4 weeks post-vaccination	4 weeks post vaccine administration	IgG response against the SARS-CoV-2 virus, measured by ELISA. GMR between the experimental and comparator arms.

Secondary Outcome Measures

Name	Time	Method
Adverse event at 1 and 4 weeks	from vaccination to 4 weeks	Self-reported adverse events at 1 week and assessed by interview at 4 weeks.
Geometric mean ratio (GMR) of IgG response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination	pre-vaccination to 4 weeks post vaccination	IgG response against the SARS-CoV-2 virus, measured by ELISA at day 0 (pre-vaccination) and at 4 weeks , GMR of each arm.
Geometric mean ratio (GMR) of Interferon-gamma (IFN-γ) response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination	pre-vaccination to 4 weeks post vaccination	IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay at day 0 (pre-vaccination) and at 4 weeks , GMR of each arm.

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Songkla, Thailand