Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,574
- 试验地点
- 3
- 主要终点
- Odds of symptomatic SARS-CoV-2 infection
研究概览
简要总结
The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil.
Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years old;
- •Resident of Toledo city;
- •Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
- •Nasal sample for SARS-CoV-2 diagnosis obtained as standard of care.
排除标准
- •SARS-CoV-2-directed antiviral treatment within the past 30 days;
- •COVID-19 monoclonal antibody therapy within the past 90 days;
- •COVID-19 convalescent serum therapy within the past 90 days;
- •Lack of consent to participate.
研究组 & 干预措施
Fully vaccinated with BNT162b2 COVID-19 vaccine
Defined as 2 doses of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective.
干预措施: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine (Drug)
Ever vaccinated with BNT162b2 COVID-19 vaccine
defined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine (Drug)
Partially vaccinated with BNT162b2 COVID-19 vaccine
Defined as 1 dose (only) of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine (Drug)
Fully vaccinated with other available COVID-19 vaccines
Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations.
干预措施: CoronaVac COVID-19 vaccine (Drug)
Fully vaccinated with other available COVID-19 vaccines
Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations.
干预措施: ChAdOx1 nCoV-19 Covid-19 Vaccine (Drug)
Fully vaccinated with other available COVID-19 vaccines
Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations.
干预措施: Ad26.COV2.S COVID-19 Vaccine (Drug)
Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine
Defined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine (Drug)
Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine
Defined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: CoronaVac COVID-19 vaccine (Drug)
Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine
Defined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: ChAdOx1 nCoV-19 Covid-19 Vaccine (Drug)
Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine
Defined as fully vaccinated with available COVID-19 vaccines according to the manufacturer recommendations plus booster dose of BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
干预措施: Ad26.COV2.S COVID-19 Vaccine (Drug)
结局指标
主要结局
Odds of symptomatic SARS-CoV-2 infection
时间窗: At the moment of enrollment
Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
次要结局
- Prevalence of long COVID-19 symptoms at 6 months(180 days after enrollment)
- Incidence of any vaccine-related adverse event(365 days from enrollment)
- Incidence of vaccine-related severe adverse event(365 days from enrollment)
- Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern(At the moment of enrollment)
- Duration of COVID-19 symptoms(within 180 days from enrollment)
- Incidence of new symptomatic COVID-19 infection(365 days from enrollment)
- Incidence of mechanical ventilation(Within 30 days from enrollment)
- Odds of symptomatic SARS-CoV-2 infection due to Gamma variant(At the moment of enrollment)
- Incidence of hospitalization due to COVID-19(Within 30 days from enrollment)
- Incidence of ICU admission(Within 30 days from enrollment)
- Mortality due to COVID-19(Within 90 days from enrollment)
- Utility score of health-related quality of life at 3 months(90 days after enrollment)