Immunogenicity to SARS-CoV-2 of Co-administering Bivalent mRNA BNT162b2 Booster and Quadrivalent Influenza Vaccine Among Healthy Volunteers: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Co-administration
Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™
干预措施: Quardrivalent influenza vaccine (Biological)
Co-administration
Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™
干预措施: Bivalent mRNA SARS-CoV-2 vaccine (Biological)
Bivalent mRNA BNT162b2
Administering a booster dose of the bivalent mRNA vaccine BNT162b2.
干预措施: Bivalent mRNA SARS-CoV-2 vaccine (Biological)
Quardrivalent influenza vaccine
Administering a VaxigripTetra™
干预措施: Quardrivalent influenza vaccine (Biological)
结局指标
主要结局
Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 4 weeks post vaccination
IgG response against the SARS-CoV-2 virus, measured by ELISA.
次要结局
未报告次要终点
研究者
Sarunyou Chusri
Principal Investigator, Clinical Professor
Prince of Songkla University