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临床试验/NCT04469634
NCT04469634已完成不适用

Are SARS-CoV-2 Specific Antibodies a Correlate for Protection?

Institute of Tropical Medicine, Belgium3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
3
主要终点
Memory B-cell function

研究概览

简要总结

The objectives of this study are (1) to determine the ex vivo neutralizing capacity and the longevity of SARS-CoV-2-specific Ab responses and (2) to measure the memory B-cell responses in a cohort of health care workers (HCW) recovering from severe, mild or asymptomatic infection. By focusing on HCW, a population that is at risk for re-infection during a second epidemic wave, the correlation between nAb levels and protection is investigated.

详细描述

SARS-CoV-2 has spread at an unprecedented speed and scale since January 2020. Since then, Belgium has been confronted with >60.000 diagnosed cases and likely many more undiagnosed with mild or no symptoms. The true seroprevalence of SARS-CoV-2 in the Belgian population is not known, yet increasing confidence about the performance of several serological assays paves the way to large-scale serosurveys. These studies will be crucial in assessing population immunity and evaluating the risk of re-infection. The first, smaller-scaled, antibody surveys report a range of seroprevalences, i.e. Germany (14%), The Netherlands (4%), USA (2.49-4.16%) and Belgium (4.7-6.9%). These studies suffer from conceptual and technical flaws yet are used for easing lockdown measures. A major limitation is that antibody (Ab) capture assays measure exposure to SARS-CoV-2, rather than subsequent protection, which requires assessment of the quality of the Abs including their capacity to neutralize the virus. Also the Ab levels required for protection and their duration are yet unknown. The proposed project aims to address these pertinent questions in a population at risk of re-infection during a second epidemic wave. Sero-neutralisation assays are regarded the gold standard method to measure ex vivo Ab neutralising activity against viruses, including SARS-CoV-2. A recent Chinese study, using a pseudovirus neutralisation assay, found that nAbs are detected from day 10-15 after onset of disease and that younger patients typically have lower levels of nAbs compared to middle-aged and elderly patients. Importantly, in about 1 out of 3 patients the nAb titers were low and in 10 young patients nAbs were absent. A pseudovirus is an imperfect model for SARS-CoV-2 because of the non-natural embedding of Spike protein in the pseudovirions and differences in glycosylation. In this study, a whole virus neutralisation assay will be used that was recently validated using a panel of SARS-CoV-2 convalescent sera in the lab of the Principal Investigator. Preliminary results of the study team show a rapid decline in nAb titer within 15-36d after diagnosis in 4/11 patients, while IgG and IgA remain steady and high in ELISA. Older studies with SARS-CoV-1 showed declining IgM and IgA antibody titers within 6 months, declining IgG titers after 1y, and a complete lack of antigen-specific peripheral memory B-cell (MBC) responses after recovery. Measuring only circulating Abs can be misleading as it excludes the detection of the MBC pool, which can exist in the absence of detectable serum Ab levels and is a pre-requisite to maintain protective immunity in the long term. Upon re-encounter with the antigen, MBC can rapidly differentiate to produce Abs. So far, little is known about humoral immune responses against SARS-CoV-2 and their contribution to protection.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be diagnosed (PCR+) with COVID-19 between March-May 2020
  • Be a permanent employee (HCW: nurse, physician, paramedical) of the study hospital
  • Agree to complete a short questionnaire and be sampled 4 tubes of heparin whole blood every 3 months over a one-year period
  • Have given their informed consent to participate

排除标准

  • Persons in serious clinical condition, incompatible with the informed consent procedure
  • Pregnant women
  • Persons that have not been diagnosed with COVID-19

结局指标

主要结局

Memory B-cell function

时间窗: 12 months

Memory B-cell function

Antibody levels over time

时间窗: 12 months

Antibody levels over time

Antibody-dependent enhancement

时间窗: 12 months

Antibody-dependent enhancement

Antibody neutralizing capacity

时间窗: 12 months

Antibody neutralizing capacity

次要结局

  • Re-infection with SARS-CoV2(12 months)

研究者

发起方
Institute of Tropical Medicine, Belgium
申办方类型
Other
责任方
Sponsor

研究点 (3)

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