BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan

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, 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

Abstract

Introduction: 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.

Materials and methods: 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.

Ethics and dissemination: 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.

Trail registration: Clinicatrials.gov: NCT05052307.

Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: Regis Goulart Rosa: has received honoraria related to investigator activities of the present study, research grants from the Brazilian Ministry of Health and Pfizer for COVID-19 studies, and honoraria for lectures from Novartis. Júlia Regazzini Spinardi: is Pfizer employee and owns Pfizer stocks. Kristen Allen: is Pfizer employee and owns Pfizer stocks. Josélia Manfio: is Moinhos de Vento employee Cintia Laura Pereira de Araujo: is Moinhos de Vento employee Mírian Cohen: is Moinhos de Vento employee and has received research grants from Medicago. Caroline Cabral Robinson: is Moinhos de Vento employee Daniel Sganzerla: has received honoraria related to statistical analysis activities of the present study. Diogo Rosas Ferreira: has received honoraria related to data managing activities of the present study. Emanuel Maltempi de Souza: has received supply of resources to perform SARS-COV-2 variant genotyping procedures of the present study. Jaqueline Carvalho de Oliveira: has received supply of resources to perform SARS-COV-2 variant genotyping procedures of the present study. Daniela Fiori Gradia: has received supply of resources to perform SARS-COV-2 variant genotyping procedures of the present study. Ana Paula Carneiro Brandalize: has received supply of resources to perform SARS-COV-2 variant genotyping procedures of the present study. Gabriela Almeida Kucharski: has no competing interests Fernando Pedrotti: has no competing interests Cristina de Oliveira Rodrigues: has received supply of resources to perform SARS-COV-2 variant genotyping procedures of the present study. Moe H. Kyaw: is Pfizer employee and owns Pfizer stocks. Graciela del Carmen Morales Castillo: is Pfizer employee and owns Pfizer stocks. Amit K. Srivastava: is Pfizer employee and owns Pfizer stocks. John M McLaughlin: is Pfizer employee and owns Pfizer stocks. Maicon Falavigna: has received honoraria related to investigator activities of the present study, consulting fees from Sanofi, Ultragenyx, Novartis, Alnylam, PTC and JCR, honoraria for lectures from Janssen, Abbvie, Sanofi, Roche, Pfizer and Novartis, and Payment for expert testimony from Merck Sharp & Dohme. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Study design.
Fig 1. Study design.
MV, mechanical ventilation; RT-PCR, reverse transcriptase polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Fig 2. Schedule of enrollment and assessment.
Fig 2. Schedule of enrollment and assessment.
N/A. Not appliable; RT-PCR, reverse transcriptase polymerase chain reaction.

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