A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| 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. |
Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| 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. |
Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| 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. |
Drug: CoronaVac COVID-19 vaccine
CoronaVac COVID-19 vaccine
Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine
ChAdOx1 nCoV-19 Covid-19 Vaccine
Drug: Janssen COVID-19 Vaccine
Janssen COVID-19 Vaccine
|
| Never vaccinated Defined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses. |
|
| 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. |
Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Drug: CoronaVac COVID-19 vaccine
CoronaVac COVID-19 vaccine
Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine
ChAdOx1 nCoV-19 Covid-19 Vaccine
Drug: Janssen COVID-19 Vaccine
Janssen COVID-19 Vaccine
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Duration of COVID-19 symptoms [within 180 days from enrollment]
Length of COVID-19-related symptoms
- 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
- Incidence of mechanical ventilation [Within 30 days from enrollment]
Incidence of invasive mechanical ventilation
- 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])
- 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 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 12 years old;
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Resident of Toledo city;
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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).
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Nasal sample for SARS-CoV-2 PCR test obtained as standard of care.
Exclusion Criteria:
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SARS-CoV-2-directed antiviral treatment within the past 30 days;
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COVID-19 monoclonal antibody therapy within the past 90 days;
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COVID-19 convalescent serum therapy within the past 90 days;
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Lack of consent to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pronto Atendimento Municipal de Toledo | Toledo | Paraná | Brazil |
Sponsors and Collaborators
- Hospital Moinhos de Vento
- Universidade Federal do Paraná
- Pfizer
- Inova Medical
Investigators
- Principal Investigator: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
- Principal Investigator: Maicon Falavigna, MD, PhD, Hospital Moinhos de Vento
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BNT162b2 in Toledo, Brazil