NCT05150834Unknown不适用
Gut Microbiota, the Potential Key to Modulating Humoral Immunogenicity of New Platform COVID-19 Vaccines: Adenovirus-vectored Vaccine Versus mRNA Vaccine
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Taxonomic biomarkers predicting immune responses
研究概览
简要总结
Vaccination is the best way to mitigate the coronavirus disease 2019 (COVID-19) pandemic, but the vaccine immunogenicity may be quite variable from person to person. There is increasing evidence suggesting that the gut microbiome is a major determinant of vaccine immunogenicity. Thus, the investigators investigated the relationship between gut microbiota and humoral immune response after COVID-19 vaccination.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People assigned to get either BNT162b2 or ChAdOx1 vaccines
- •informed concents
排除标准
- •Participants were excluded if they had a history of medication which would affect gut microbiota in the past 1 month, including antibiotics, laxatives, and motility drugs.
结局指标
主要结局
Taxonomic biomarkers predicting immune responses
时间窗: before the administration of first-dose
This study aimed to analyze whether fecal microbiota composition before vaccination was associated with immmune response level
次要结局
- Antibody titres after the first dose vaccination(3weeks from the first-dose administration in BNT162b2 group, 8-12weeks from the first-dose administration in ChAdOx1)
- Antibody titres after the second dose vaccination(3 weeks from the second dose administration in both BNT162b2 and ChAdOx1 groups)
研究者
Hye Seong
clinical professor
Korea University Guro Hospital
研究点 (1)
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