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临床试验/NCT04842305
NCT04842305Unknown不适用

Induction of SARS-CoV-2 Spike Glycoprotein Antibodies in Saliva and Plasma in Response to a COVID-19 Infection, Systemic COVID-19 Vaccination, and the Combination of COVID-19 and Vaccination

Lenanrt Friis-Hansen0 个研究点目标入组 500 人开始时间: 2021年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
主要终点
Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma

研究概览

简要总结

The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Both Hospital staff as well as non-health care workers will be invited to participate

排除标准

  • Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
  • Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.

结局指标

主要结局

Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma

时间窗: Between 21 and 200 days after infection/vaccination

Detection of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma in participants who have been infected with COVID-19, vaccinated with Pfizer-BioNTech/Moderna mRNA-1273/AstraZeneca or infected and vaccinated

次要结局

  • Titer of SARS-CoV-2 spike glycoprotein RBD antibodies in saliva and plasma(Between 21 and 200 days after vaccination)

研究者

发起方
Lenanrt Friis-Hansen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lenanrt Friis-Hansen

Department of Clinical Biochemistry MD, DMSc, Principal Investigator

University Hospital Bispebjerg and Frederiksberg

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