Different Significance of Reactogenicity in Immunogenicity and Inflammatory Response by New COVID-19 Vaccine Platforms: BNT162b2 mRNA Versus ChAdOx1 nCoV19 Vaccine
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- IL-6, TNF-α, and IL-1ß
研究概览
简要总结
Analysis of humoral antibody and cytokine kinetics after vaccination with either BNT162b2 or ChAdOx1 nCoV-19 vaccine and factors influencing the vaccine immunogenicity
详细描述
There is a different aspect of reactogenicity between BNT162b2 and ChAdOx1 nCoV-19 vaccine. Both new platform vaccines were concerned if they would elicit more significant local or systemic reactogenicity compared to the conventional vaccines. Previous studies had reported that immune cells such as mast cells and macrophages are activated just after vaccination, and release proinflammatory cytokines such as interleukin (IL)-6 and tumor necrosis factor (TNF)-α. The post-vaccination kinetics of inflammatory cytokines would be variable by each vaccine platform, and might be associated with reactogenicity. It is an interesting issue to be investigated whether the reactogenicity following newly developed BNT162b2 and ChAdOx1 would be associated with immunogenicity and inflammatory response or not. To better clarify these uncertainties, we evaluated the change of antibody response between BNT162b2 and ChAdOx1 over three months post-vaccination, in relation to the kinetics of inflammatory cytokines and reactogenicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers who provide the informed consent after either BNT162b2 or ChAdOx1 vaccination
- •healthy adults without underlying medical condition
排除标准
- •Volunteers who had ever infected with SARS-CoV2 were excluded.
结局指标
主要结局
IL-6, TNF-α, and IL-1ß
时间窗: At 3 days after the second-dose
measured by flexible customized bead-based multiplex panels for Luminex assays (Human Premixed Multi-Analyte Kit, R\&D Systems Inc., Minneapolis, MN, USA).
Immunoglobulin G (IgG) anti-S antibodies
时间窗: At 3 weeks after the second-dose vaccination (T2)
measured using the Elecsys® Anti-SARS-CoV-2 S assay (Roche, Rotkreuz, Switzerland)
Neutralizing antibodies
时间窗: At 3 weeks after the second-dose vaccination (T2)
Reduction in plaque count of 50% (PRNT50) was calculated for the median neutralizing titer (ND50) using the Spearman-Karber formula
reactogenicity after vaccination
时间窗: Until post-vaccination day 7
Local erythema/swelling was regarded as positive sign if larger than 2.5 cm in diameter. Systemic adverse events were graded as follows: grade 0, no systemic adverse event; grade 1, any adverse event that did not interfere with activity; grade 2, any adverse event that interfered with daily activity. Fever was classified as grade 1 (from 37.5℃ to 38.4℃) and grade 2 (\>38.5℃). Systemic adverse events were classified into two ways: (i) the highest level of severity of any adverse event reported by the participants and (ii) with or without specific adverse event.
次要结局
- The correlation between humoral immune response and reactogenicity after vaccination(The correlation between reactogenicity after the first dose and immunogenicity at T1 (3 weeks after dose 1 prior to dose 2) and T2 (3 weeks after dose 2);the correlation between reactogenicity after vaccine dose 2 and immunogenicity at T2)
- The correlation between cytokine response and reactogenicity after vaccination(At 3 days after each dose)
- Long-term immunogenicity: Immunoglobulin G (IgG) anti-S antibodies(At 3 months after the second vaccination (T3))
研究者
Joon Young Song
Principal Investigator
Korea University Guro Hospital