BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.
<h4>Introduction</h4>Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0276384 |
| _version_ | 1797989713099882496 |
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| author | Regis Goulart Rosa Julia Spinardi Kristen E Allen Josélia Manfio Cintia Laura Pereira de Araujo Mírian Cohen Caroline Cabral Robinson Daniel Sganzerla Diogo Ferreira Emanuel Maltempi de Souza Jaqueline Carvalho de Oliveira Daniela Fiori Gradia Ana Paula Carneiro Brandalize Gabriela Almeida Kucharski Fernando Pedrotti Cristina de Oliveira Rodrigues Moe H Kyaw Graciela Del Carmen Morales Castillo Amit Srivastava John M McLaughlin Maicon Falavigna |
| author_facet | Regis Goulart Rosa Julia Spinardi Kristen E Allen Josélia Manfio Cintia Laura Pereira de Araujo Mírian Cohen Caroline Cabral Robinson Daniel Sganzerla Diogo Ferreira Emanuel Maltempi de Souza Jaqueline Carvalho de Oliveira Daniela Fiori Gradia Ana Paula Carneiro Brandalize Gabriela Almeida Kucharski Fernando Pedrotti Cristina de Oliveira Rodrigues Moe H Kyaw Graciela Del Carmen Morales Castillo Amit Srivastava John M McLaughlin Maicon Falavigna |
| author_sort | Regis Goulart Rosa |
| collection | DOAJ |
| description | <h4>Introduction</h4>Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations.<h4>Materials and methods</h4>A test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases are RT-PCR positive and controls RT-PCR negative. Test-positive cases are prospectively followed through structured telephone interviews performed at 15 days post-enrollment, and at 1, 3, 6, 9 and 12 months. Baseline demographic, clinical, and vaccination data are being collected by means of structured interviews and medical registry records reviews at the time of enrollment. All RT-PCR-positive samples are screened for mutations to identify SARS-CoV-2 variants.<h4>Ethics and dissemination</h4>The study protocol has been approved by the research ethics committee of all participant sites. Study findings will be disseminated through peer-reviewed publications and conference presentations.<h4>Trail registration</h4>Clinicatrials.gov: NCT05052307. |
| first_indexed | 2024-04-11T08:24:51Z |
| format | Article |
| id | doaj.art-8b1c76db84e4419cbe5a793f51b38846 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-11T08:24:51Z |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-8b1c76db84e4419cbe5a793f51b388462022-12-22T04:34:49ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-011710e027638410.1371/journal.pone.0276384BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.Regis Goulart RosaJulia SpinardiKristen E AllenJosélia ManfioCintia Laura Pereira de AraujoMírian CohenCaroline Cabral RobinsonDaniel SganzerlaDiogo FerreiraEmanuel Maltempi de SouzaJaqueline Carvalho de OliveiraDaniela Fiori GradiaAna Paula Carneiro BrandalizeGabriela Almeida KucharskiFernando PedrottiCristina de Oliveira RodriguesMoe H KyawGraciela Del Carmen Morales CastilloAmit SrivastavaJohn M McLaughlinMaicon Falavigna<h4>Introduction</h4>Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations.<h4>Materials and methods</h4>A test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases are RT-PCR positive and controls RT-PCR negative. Test-positive cases are prospectively followed through structured telephone interviews performed at 15 days post-enrollment, and at 1, 3, 6, 9 and 12 months. Baseline demographic, clinical, and vaccination data are being collected by means of structured interviews and medical registry records reviews at the time of enrollment. All RT-PCR-positive samples are screened for mutations to identify SARS-CoV-2 variants.<h4>Ethics and dissemination</h4>The study protocol has been approved by the research ethics committee of all participant sites. Study findings will be disseminated through peer-reviewed publications and conference presentations.<h4>Trail registration</h4>Clinicatrials.gov: NCT05052307.https://doi.org/10.1371/journal.pone.0276384 |
| spellingShingle | Regis Goulart Rosa Julia Spinardi Kristen E Allen Josélia Manfio Cintia Laura Pereira de Araujo Mírian Cohen Caroline Cabral Robinson Daniel Sganzerla Diogo Ferreira Emanuel Maltempi de Souza Jaqueline Carvalho de Oliveira Daniela Fiori Gradia Ana Paula Carneiro Brandalize Gabriela Almeida Kucharski Fernando Pedrotti Cristina de Oliveira Rodrigues Moe H Kyaw Graciela Del Carmen Morales Castillo Amit Srivastava John M McLaughlin Maicon Falavigna BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. PLoS ONE |
| title | BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. |
| title_full | BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. |
| title_fullStr | BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. |
| title_full_unstemmed | BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. |
| title_short | BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan. |
| title_sort | bnt162b2 against covid 19 in brazil using a test negative design study protocol and statistical analysis plan |
| url | https://doi.org/10.1371/journal.pone.0276384 |
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