COVID - 19
Conditions
Keywords
co-administration, immunogenicity, cell-medicated immune response, influenza vaccine, COVID-19 vaccine, SARS-CoV-2 vaccine
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.
Interventions
BIOLOGICALBivalent mRNA SARS-CoV-2 vaccine
Administering a booster dose of the bivalent mRNA vaccine BNT162b2
BIOLOGICALQuardrivalent influenza vaccine
Administering a VaxigripTetra™
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | Before vaccination | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay |
| Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | 4 weeks post vaccination | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay |
| Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | before vaccination | IgG response against the SARS-CoV-2 virus, measured by ELISA. |
| Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | 4 weeks post vaccination | IgG response against the SARS-CoV-2 virus, measured by ELISA. |
Countries
Thailand
Participant flow
Recruitment details
Volunteers were recruited between March and April 2024 at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
Pre-assignment details
A total of 42 adults were screened for eligibility. Six were excluded because of uncontrolled chronic diseases, leaving 36 participants who were randomized.
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Vaccine Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination | 12 |
| Influenza Vaccine Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination | 12 |
| Co-administration Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination | 12 |
| Total | 36 |
Baseline characteristics
| Characteristic | COVID-19 Vaccine | Influenza Vaccine | Co-administration | Total |
|---|---|---|---|---|
| Age, Continuous | 28 year | 39 year | 29 year | 31 year |
| Duration from last COVID-19 vaccination | 90 week | 85.5 week | 85.5 week | 87.5 week |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 10 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks
IgG response against the SARS-CoV-2 virus, measured by ELISA.
Time frame: 4 weeks post vaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| COVID-19 vaccine | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | 10456.1 BAU/mL |
| Influenza vaccine | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | 1008.0 BAU/mL |
| Co-administration | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | 8558.7 BAU/mL |
Primary
Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline
IgG response against the SARS-CoV-2 virus, measured by ELISA.
Time frame: before vaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| COVID-19 vaccine | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | 1276.3 BAU/mL |
| Influenza vaccine | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | 1074.2 BAU/mL |
| Co-administration | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | 1299.7 BAU/mL |
Primary
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks
IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay
Time frame: 4 weeks post vaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| COVID-19 vaccine | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | 59.9 SFCs/10⁶ PBMCs |
| Influenza vaccine | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | 15.2 SFCs/10⁶ PBMCs |
| Co-administration | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | 61.6 SFCs/10⁶ PBMCs |
Primary
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline
IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay
Time frame: Before vaccination
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| COVID-19 vaccine | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | 19.6 SFCs/10⁶ PBMCs |
| Influenza vaccine | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | 14 SFCs/10⁶ PBMCs |
| Co-administration | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | 12.6 SFCs/10⁶ PBMCs |