Effectiveness of Vaccination Against COVID-19 in Brazil: Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,920
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of the vaccination against COVID-19.
研究概览
简要总结
The main objective of the study is to evaluate the effectiveness of the vaccine against covid-19, recommended by the national immunization program. This is a multicentric, observational, case-control study. Participants Cases with the disease will be compared to Control Participants, that is, without the disease, regarding the vaccination history for Covid-19.Complementarily, an evaluation of cellular and humoral immunity will be carried out in a sample of both case and control participants, taking into account the vaccination history.
详细描述
The Covid-19 vaccines currently distributed by the National Immunization Program (NIP) have undergone a rigorous safety and efficacy assessment by the National Surveillance Agency Sanitary prior to the authorization of use in the country. The main objective of vaccination against Covid19 is to reduce its morbidity and mortality and, in the future, to promote the control of transmission from the prevention of symptomatic cases in the general population.
To achieve this goal, however, it is important that the vaccines are administered correctly (according to the vaccination schedule correct application techniques and appropriate storage conditions, for example), in the selected population groups (according to prioritization criteria), with vaccination coverage and selected population groups (according to prioritization criteria), with vaccination coverage and vaccination speeds sufficient for effective control of the disease.That is, there are factors that extrapolate the issues of quality, efficacy and safety evaluated in the pre-registration stages, which are extremely important for the success of immunization programs. Thus, the monitoring of these parameters after large-scale use is essential to ratify the favorable risk-benefit assessment made at the time of decision on the introduction of these vaccines in the NIP.
Regarding the role of vaccines in the prevention and control of target diseases, in addition to data from efficacy and immunogenicity obtained in the controlled situations of clinical trials, it is necessary to extend this assessment to routine situations, i.e., "real life", based on the so-called effectiveness studies. Factors such as storage and administration conditions of these products, issues related to vaccinated populations and individuals may affect the response to vaccines.
Therefore, the monitoring of effectiveness must be continuous, seeking to prove the impact of the vaccines in reducing the occurrence of the disease, as well as generating vaccine immunogenicity data, which can be used in the future as protective inferences in complementary analyses.
Thus, the present research project is a study of the effectiveness of the vaccination whereas the efficacy of licensed vaccines, demonstrated in controlled studies, that needs to be verified in the routine of immunization services throughout the country, with its diversity including different vaccination coverage and circulation of SARS-CoV-2 variants, as well as individual factors, such as age group and presence of comorbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreement to participate in the study after reading, understanding and signing the informed consent.
- •Availability and possibility of being followed up during the follow-up period defined in the study, through visits to research centers, home visits, telephone contacts or other means of digital communication.
- •Completing the case or control definitions described below.
排除标准
- •Behavioral, cognitive or psychiatric illness that, in the opinion of the responsible investigator or his/her medical representative, affects the participant's ability to understand and comply with the requirements of the study protocol;
- •Any other condition that, in the opinion of the responsible investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or prevent him/her from complying with this protocol.
结局指标
主要结局
Evaluate the effectiveness of the vaccination against COVID-19.
时间窗: 12 months
Confirmed disease (RT-PCR positive for SARS-CoV-2), according to:the clinical spectrum (of mild disease , moderate to severe) and outcome (disease-related death);according to the vaccine used, the number of doses and the interval rom the last dose to the onset of symptom;according to the presence of comorbidities and medication use; according to Region/State;according to vaccination coverage;according to circulating viral variants.
次要结局
- Assess the humoral and cellular immune response(15 months)
- Analyze individual factors(15 months)