JPRN-UMIN000048434已完成未知
Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers used for evaluation of COVID-19 nasal vaccine - Clinical study to establish a method for measuring Anti-SARS-CoV-2 spike-specific antibody titers
Chiba University Hospital Department of Human Mucosal Vaccinology0 个研究点目标入组 45 人开始时间: 2022年7月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •[Cohort A: Those who are expected to exert mucosal immunity and meet the following conditions (1) and (2)] (1) Has a history of SARS-CoV-2 positive judgment (2) COVID-19 mRNA vaccine has been inoculated after SARS-CoV-2 infection, and it is within 90 days of vaccination at the time of consent acquisition. [Cohort B: Those who are expected not to exert mucosal immunity and meet the following conditions (1) and (2)] (1) No history of SARS-CoV-2 infection (including suspected infection) (2) No history of COVID-19 vaccination, or more than 180 days have passed since COVID-19 vaccination at the time of consent acquisition. [Common to Cohort A, B] Those who have received sufficient explanation in participating in this research, and who have obtained the voluntary written consent of the research subject after sufficient understanding. [Standards common to cohorts A and B] 1) Those who have not passed 14 days since the onset of SARS-CoV-2 2) Those who have an otolaryngology disease (however, pollinosis in the non-scattering period is not excluded) and are judged to be ineligible by the principal investigator or the research coordinator. 3) Those who have periodontal disease and are judged to be ineligible by the principal investigator or the research coordinator. 4) Pregnant women 5) Others who are judged to be ineligible by the principal investigator or the research coordinator It was [Criteria for Cohort A only] 6) Those who are receiving steroids (excluding external preparations) or immunosuppressants 7) Persons suffering from diseases associated with immunosuppression such as acquired immunodeficiency syndrome
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