Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity.
SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates.
In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpot™ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLD™ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Paul A. Gurbel, MD
- 电话号码:410-601-5475
- 邮箱:pgurbel@lifebridgehealth.org
研究联系人备份
- 姓名:Kevin Bliden, MBA
- 电话号码:410-601-5475
- 邮箱:kbliden@lifebridgehealth.org
学习地点
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Maryland
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Baltimore、Maryland、美国、21215
- 招聘中
- Sinai Hospital
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接触:
- kevin bliden, MBA
- 电话号码:443-244-1497
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接触:
- Udaya Tantry, PhD
- 电话号码:410-707-2655
- 邮箱:utantry@lifebridgehealth.org
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Adult males or females aged 18 years and older (inclusive) at screening.
- Able and willing (in the investigator's opinion) to comply with all study requirements.
- Willing to discuss their relevant medical history with the study investigators.
- Willing and able to give informed consent prior to study enrollment.
Exclusion Criteria:
- History of a recent or previous COVID-19 infection per history or as detected by either the PGOLD™COVID-19 IGG/IGM ASSAY or MidaSpot™ COVID-19 Antibody fingerstick test.
学习计划
研究是如何设计的?
设计细节
- 观测模型:案例交叉
- 时间观点:预期
队列和干预
团体/队列 |
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Group 1: Recipients of BNT162b2 mRNA Covid-19 Vaccine
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Group 2: Recipients of mRNA-1273 SARS-CoV-2 Vaccine
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Presence of IgG and IgM antibodies to SARS-CoV-2 in response to vaccination
大体时间:3 months
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Detection and quantification of IgG and IgM antibodies to SARS-CoV-2 by the antibody-avidity assay test
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3 months
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Loss of IgG and IgM antibodies to SARS-CoV-2
大体时间:12 months
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Loss of IgG and IgM antibodies to SARS-CoV-2 when tested by the antibody-avidity assay test and rapid COVID-19 Antibody Combo Detection Kit at days 0, 20, 45, 70, 3 months, 6 months, 9 months, 12 months post-vaccination, after initial detection of antibodies
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Thrombo-inflammatory syndrome
大体时间:12 months
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Frequency of thrombo-inflammatory syndrome as defined by urinary 11-dehdro thromboxane > 4200 pg/mg in subjects experiencing a moderate-severe reaction to immunization
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12 months
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Side effects
大体时间:12 months
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he occurrence and severity of reactogenicity in terms of solicited local and systemic adverse events after each vaccination for the duration of 1 year.
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12 months
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Hypercoagulability
大体时间:12 months
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Frequency of hypercoagulability as defined by increased platelet fibrin-clot strength as measured by Thrombelastography in subjects experiencing a moderate-severe reaction to immunization
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12 months
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合作者和调查者
调查人员
- 研究主任:Kevin Bliden, MBA、Sinai Center for Thrombosis Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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