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| Name | Class |
|---|---|
| Universidade Federal do Paraná | OTHER |
| Pfizer | INDUSTRY |
| Inova Medical | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Never vaccinated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine | Drug | Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Odds of symptomatic SARS-CoV-2 infection | 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). | At the moment of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Odds of symptomatic SARS-CoV-2 infection due to Gamma variant | 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 | At the moment of enrollment |
| Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern |
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Inclusion Criteria:
Exclusion Criteria:
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The present study population will be composed by individuals aged 12 years or older who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. 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.
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| Name | Affiliation | Role |
|---|---|---|
| Regis G Rosa, MD, PhD | Hospital Moinhos de Vento | Principal Investigator |
| Maicon Falavigna, MD, PhD | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pronto Atendimento Municipal de Toledo | Toledo | Paraná | Brazil | |||
| Unidade Básica de Saúde Jardim Cosmos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36264905 | Background | Goulart Rosa R, Spinardi J, Allen KE, Manfio J, de Araujo CLP, Cohen M, Robinson CC, Sganzerla D, Ferreira D, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Kucharski GA, Pedrotti F, Rodrigues CO, Kyaw MH, Castillo GDCM, Srivastava A, McLaughlin JM, Falavigna M. BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. PLoS One. 2022 Oct 20;17(10):e0276384. doi: 10.1371/journal.pone.0276384. eCollection 2022. | |
| 37507274 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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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. |
|
| CoronaVac COVID-19 vaccine | Drug | CoronaVac COVID-19 vaccine |
|
| ChAdOx1 nCoV-19 Covid-19 Vaccine | Drug | ChAdOx1 nCoV-19 Covid-19 Vaccine |
|
| Ad26.COV2.S COVID-19 Vaccine | Drug | Ad26.COV2.S COVID-19 Vaccine |
|
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 |
| At the moment of enrollment |
| Duration of COVID-19 symptoms | Length of COVID-19-related symptoms | within 180 days from enrollment |
| Incidence of hospitalization due to COVID-19 | Incidence of hospital admission due to COVID-19 | Within 30 days from enrollment |
| Incidence of ICU admission | Incidence of ICU admission | Within 30 days from enrollment |
| Incidence of mechanical ventilation | Incidence of invasive mechanical ventilation | Within 30 days from enrollment |
| Mortality due to COVID-19 | Incidence of COVID-19-related mortality | Within 90 days from enrollment |
| Utility score of health-related quality of life at 3 months | 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]) | 90 days after enrollment |
| Prevalence of long COVID-19 symptoms at 6 months | 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) | 180 days after enrollment |
| Incidence of new symptomatic COVID-19 infection | 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 | 365 days from enrollment |
| Incidence of any vaccine-related adverse event | Incidence of any vaccine-related adverse event including local pain, hyperemia or necrosis; fever; fatigue; headache; myalgia; arthralgia; vomiting; diarrhea; and other symptoms | 365 days from enrollment |
| Incidence of vaccine-related severe adverse event | Incidence of any adverse event that result in death, hospitalization or prolongation of hospitalization, and persistent or significant disability | 365 days from enrollment |
| Toledo |
| Paraná |
| Brazil |
| Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha | Toledo | Paraná | Brazil |
| Background |
| Rosa RG, Falavigna M, Manfio JL, de Araujo CLP, Cohen M, do Valle Barbosa GRG, de Souza AP, Romeiro Silva FK, Sganzerla D, da Silva MMD, Ferreira D, de Oliveira Rodrigues C, de Souza EM, de Oliveira JC, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Spinardi J, Del Carmen Morales Castillo G, McLaughlin JM; Toledo BNT16b2 Study Group Investigators. BNT162b2 mRNA COVID-19 against symptomatic Omicron infection following a mass vaccination campaign in southern Brazil: A prospective test-negative design study. Vaccine. 2023 Aug 23;41(37):5461-5468. doi: 10.1016/j.vaccine.2023.07.038. Epub 2023 Jul 26. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |