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

Covid19 Clinical Trial

Official title:

Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052307
• Other study ID #: BNT162b2 in Toledo, Brazil
• Status: Completed
• Start date: November 3, 2021
• Est. completion date: July 20, 2023

Study information

• Verified date: February 2023
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4574
• Est. completion date: July 20, 2023
• Est. primary completion date: June 20, 2022
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
• CoronaVac COVID-19 vaccine
CoronaVac COVID-19 vaccine
• ChAdOx1 nCoV-19 Covid-19 Vaccine
ChAdOx1 nCoV-19 Covid-19 Vaccine
• Ad26.COV2.S COVID-19 Vaccine
Ad26.COV2.S COVID-19 Vaccine

Locations

Country	Name	City	State
Brazil	Pronto Atendimento Municipal de Toledo	Toledo	Paraná
Brazil	Unidade Básica de Saúde Jardim Cosmos	Toledo	PR
Brazil	Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha	Toledo	PR

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Inova Medical, Pfizer, Universidade Federal do Paraná

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern	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
Secondary	Duration of COVID-19 symptoms	Length of COVID-19-related symptoms	within 180 days from enrollment
Secondary	Incidence of hospitalization due to COVID-19	Incidence of hospital admission due to COVID-19	Within 30 days from enrollment
Secondary	Incidence of ICU admission	Incidence of ICU admission	Within 30 days from enrollment
Secondary	Incidence of mechanical ventilation	Incidence of invasive mechanical ventilation	Within 30 days from enrollment
Secondary	Mortality due to COVID-19	Incidence of COVID-19-related mortality	Within 90 days from enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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