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)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 6,233
- 试验地点
- 1
- 主要终点
- Incidence density of moderate and severe clinical cases of COVID-19
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Adsorbed SARS-CoV-2 (inactivated) vaccine (Biological)
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.
结局指标
主要结局
Incidence density of moderate and severe clinical cases of COVID-19
时间窗: 2 weeks after the second vaccine dose
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.
次要结局
- Adverse events(Up to 7 days after each dose of the vaccine (Day 7 and Day 35))
- Incidence density of moderate and severe clinical cases of COVID-19 after second dose(After second dose, up to 12 months.)
- Incidence density of severe clinical cases of COVID-19 after second dose(After second dose, up to 12 months.)
- Mortality confirmed as COVID-19(After first dose, up to 12 months.)
- Incidence density of hospitalizations for any cause(After first dose, up to 12 months.)
- Mortality from any cause(After first dose, up to 12 months.)
- Median of clinical progression scores between moderate and severe cases(After first dose, up to 12 months.)
- Detection of antibodies against SARS-CoV-2 in samples(Before each vaccine dose and every 3 months, up to 12 months of follow-up)
- Incidence density of moderate and severe clinical cases of COVID-19 after first dose(After first dose, up to 12 months.)
- Humoral and cell-mediated immune response(Before each vaccine dose and every 3 months, up to 12 months of follow-up.)
- Incidence density of clinical cases virologically confirmed as COVID-19(After first dose, up to 12 months.)