A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil
- Conditions
- Covid19
- Interventions
- Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDrug: CoronaVac COVID-19 vaccineDrug: ChAdOx1 nCoV-19 Covid-19 VaccineDrug: Ad26.COV2.S COVID-19 Vaccine
- Registration Number
- NCT05052307
- Lead Sponsor
- Hospital Moinhos de Vento
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4574
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine Ad26.COV2.S 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. Ever vaccinated with BNT162b2 COVID-19 vaccine Pfizer/BioNTech BNT162b2 mRNA 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. Fully vaccinated with other available COVID-19 vaccines Ad26.COV2.S COVID-19 Vaccine Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations. Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine CoronaVac 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. Fully vaccinated with BNT162b2 COVID-19 vaccine Pfizer/BioNTech BNT162b2 mRNA 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. Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine Pfizer/BioNTech BNT162b2 mRNA 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. Fully vaccinated with other available COVID-19 vaccines CoronaVac COVID-19 vaccine Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations. Fully vaccinated with other available COVID-19 vaccines ChAdOx1 nCoV-19 Covid-19 Vaccine Defined as fully vaccinated with available COVID-19 vaccines other than the BNT162b2 according to the manufacturer recommendations. Partially vaccinated with BNT162b2 COVID-19 vaccine Pfizer/BioNTech BNT162b2 mRNA 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. Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine ChAdOx1 nCoV-19 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.
- Primary Outcome Measures
Name Time Method Odds of symptomatic SARS-CoV-2 infection 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).
- Secondary Outcome Measures
Name Time Method Prevalence of long COVID-19 symptoms at 6 months 180 days after enrollment Incidence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache, anxiety, and depression)
Incidence of any vaccine-related adverse event 365 days from enrollment Incidence of any vaccine-related adverse event including local pain, hyperemia or necrosis; fever; fatigue; headache; myalgia; arthralgia; vomiting; diarrhea; and other symptoms
Incidence of vaccine-related severe adverse event 365 days from enrollment Incidence of any adverse event that result in death, hospitalization or prolongation of hospitalization, and persistent or significant disability
Duration of COVID-19 symptoms within 180 days from enrollment Length of COVID-19-related symptoms
Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern At the moment of enrollment Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Alfa, Beta, or Delta variant
Incidence of new symptomatic COVID-19 infection 365 days from enrollment Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection
Incidence of mechanical ventilation Within 30 days from enrollment Incidence of invasive mechanical ventilation
Odds of symptomatic SARS-CoV-2 infection due to Gamma variant At the moment of enrollment Odds of symptomatic SARS-CoV-2 infection due to Gamma variant defined by the presence of symptoms suggestive COVID-19 with a positive PCR test for SARS-CoV-2 Gamma variant
Incidence of hospitalization due to COVID-19 Within 30 days from enrollment Incidence of hospital admission due to COVID-19
Incidence of ICU admission Within 30 days from enrollment Incidence of ICU admission
Mortality due to COVID-19 Within 90 days from enrollment Incidence of COVID-19-related mortality
Utility score of health-related quality of life at 3 months 90 days after enrollment Utility score of health-related quality of life assessed with the EuroQol- 5 dimensions 3-level questionnaire. The utility score derived from the descriptive system for the Brazilian population ranges from -0.176 (indicating the worst health status \[serious problems in all domains\]) to 1.0 (indicating the best health status \[no problems at all\])
Trial Locations
- Locations (3)
Unidade Básica de Saúde Jardim Cosmos
🇧🇷Toledo, PR, Brazil
Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha
🇧🇷Toledo, PR, Brazil
Pronto Atendimento Municipal de Toledo
🇧🇷Toledo, Paraná, Brazil