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临床试验/NCT05060939
NCT05060939已完成不适用

Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 1,072 人开始时间: 2021年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,072
试验地点
2
主要终点
Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients

研究概览

简要总结

Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 18 years old
  • Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
  • Persons affiliated to a social security scheme or beneficiary of such a scheme

排除标准

  • - Pregnant or lactating woman

结局指标

主要结局

Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients

时间窗: At inclusion

Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples

次要结局

  • Titers of SARS-CoV-2 antibodies(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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