Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity (COVACMANAUS)
2021年7月22日 更新者：Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)
This is a quasi-experimental study with risk-based allocation.
Public security and education professionals from the state government will be included.
In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19.
Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days).
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after).
All participants will be followed up for 12 months from inclusion in the study.
Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.
研究概览
研究类型
介入性
注册 (实际的)
6233
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Amazonas
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Manaus、Amazonas、巴西、69050-010
- Escola Normal Superior - Universidade do Estado do Amazonas
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 18 and 49 years
- Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.
Exclusion Criteria:
- Prior vaccination for COVID-19;
- Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
- History of severe allergic reaction or anaphylaxis to study vaccine components;
- Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
- Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
- Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
- Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
- Pregnancy or breastfeeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：High-risk individuals (with comorbidities)
Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine
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600 SU/dose; Two doses separated by 28 days (± 7 days).
Intramuscular (deltoid) administration.
其他名称：
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无干预：Low-risk individuals (without comorbidities)
Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.
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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 |
|---|---|---|
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Incidence density of moderate and severe clinical cases of COVID-19
大体时间：2 weeks after the second vaccine dose
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Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.
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2 weeks after the second vaccine dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence density of moderate and severe clinical cases of COVID-19 after first dose
大体时间：After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose
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After first dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 after second dose
大体时间：After second dose, up to 12 months.
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Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 after second dose
大体时间：After second dose, up to 12 months.
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Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose
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After second dose, up to 12 months.
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Median of clinical progression scores between moderate and severe cases
大体时间：After first dose, up to 12 months.
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Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups
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After first dose, up to 12 months.
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Incidence density of clinical cases virologically confirmed as COVID-19
大体时间：After first dose, up to 12 months.
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After first dose, up to 12 months.
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Mortality confirmed as COVID-19
大体时间：After first dose, up to 12 months.
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Incidence density of deaths confirmed as COVID-19
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After first dose, up to 12 months.
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Incidence density of hospitalizations for any cause
大体时间：After first dose, up to 12 months.
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After first dose, up to 12 months.
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Mortality from any cause
大体时间：After first dose, up to 12 months.
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Density of mortality from any cause
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After first dose, up to 12 months.
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Adverse events
大体时间：Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Frequency of adverse events associated with the need for medical care
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Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
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Humoral and cell-mediated immune response
大体时间：Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants
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Before each vaccine dose and every 3 months, up to 12 months of follow-up.
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Detection of antibodies against SARS-CoV-2 in samples
大体时间：Before each vaccine dose and every 3 months, up to 12 months of follow-up
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Before each vaccine dose and every 3 months, up to 12 months of follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marcus Lacerda, MD、Fundação de Medicina Tropical Heitor Vieira Dourado
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年3月18日
初级完成 (实际的)
2021年7月5日
研究完成 (预期的)
2022年3月1日
研究注册日期
首次提交
2021年3月5日
首先提交符合 QC 标准的
2021年3月8日
首次发布 (实际的)
2021年3月9日
研究记录更新
最后更新发布 (实际的)
2021年7月26日
上次提交的符合 QC 标准的更新
2021年7月22日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.