A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil

NCT05052307 | Completed FDA Drug

• 1 other identifier: BNT162b2 in Toledo, Brazil
• Study Type: observational
• Target: 4,574
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Keywords

COVID-19; Mass vaccination

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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 other circulating variants of concern

  At the moment of enrollment

• Duration of COVID-19 symptoms

  within 180 days from enrollment

• Incidence of hospitalization due to COVID-19

  Within 30 days from enrollment

• Incidence of ICU admission

  Within 30 days from enrollment

Study Arms (6)

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

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

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

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; Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine; Drug: Ad26.COV2.S 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; Drug: CoronaVac COVID-19 vaccine; Drug: ChAdOx1 nCoV-19 Covid-19 Vaccine; Drug: Ad26.COV2.S COVID-19 Vaccine

Interventions

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Ever vaccinated with BNT162b2 COVID-19 vaccine; Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine; Fully vaccinated with BNT162b2 COVID-19 vaccine; Partially vaccinated with BNT162b2 COVID-19 vaccine

CoronaVac COVID-19 vaccine DRUG

CoronaVac COVID-19 vaccine

Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine; Fully vaccinated with other available COVID-19 vaccines

ChAdOx1 nCoV-19 Covid-19 Vaccine DRUG

ChAdOx1 nCoV-19 Covid-19 Vaccine

Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine; Fully vaccinated with other available COVID-19 vaccines

Ad26.COV2.S COVID-19 Vaccine DRUG

Ad26.COV2.S COVID-19 Vaccine

Fully vaccinated plus booster dose of BNT162b2 COVID-19 vaccine; Fully vaccinated with other available COVID-19 vaccines

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Universidade Federal do Paraná: collaborator
• Pfizer: collaborator
• Inova Medical: collaborator

Study Sites (3)

Pronto Atendimento Municipal de Toledo

Toledo, Paraná, Brazil

Location

Unidade Básica de Saúde Jardim Cosmos

Toledo, Paraná, Brazil

Location

Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha

Toledo, Paraná, Brazil

Location

Related Publications (2)

• 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.

  PMID: 36264905 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.

  PMID: 37507274 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine; Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Regis G Rosa, MD, PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

• Maicon Falavigna, MD, PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 22, 2021
• Study Start: November 3, 2021
• Primary Completion: June 20, 2022
• Study Completion: July 20, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)