Clinical trial NCT06831786: Immunogenicity of COVID-19 Vaccine Co-administration with Influenza Vaccine in Healthy Volunteers
Official title: Immunogenicity to SARS-CoV-2 of Co-administering Bivalent MRNA BNT162b2 Booster and Quadrivalent Influenza Vaccine Among Healthy Volunteers: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Immune Response to SARS-CoV-2
Keywords: co-administration
immunogenicity
cell-medicated immune response
influenza vaccine
COVID-19 vaccine
SARS-CoV-2 vaccine
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric mean ratio (GMR) of Interferon-gamma (IFN-γ) response against the SARS-CoV-2 virus at 4 weeks post-vaccination
timeFrame: 4 weeks post vaccine administration
measure: Geometric mean ratio (GMR) of IgG response against the SARS-CoV-2 virus at 4 weeks post-vaccination
timeFrame: 4 weeks post vaccine administration
Secondary outcomes:
measure: Adverse event at 1 and 4 weeks
timeFrame: from vaccination to 4 weeks
measure: Geometric mean ratio (GMR) of IgG response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination
timeFrame: pre-vaccination to 4 weeks post vaccination
measure: Geometric mean ratio (GMR) of Interferon-gamma (IFN-γ) response against the SARS-CoV-2 virus between pre and 4 weeks post vaccination
timeFrame: pre-vaccination to 4 weeks post vaccination
Other outcomes:
Locations:
city: Songkla
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
Study officials:
affiliation: Prince of Songkla University
name: Sarunyou Chusri, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: