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Effectiveness of the Fiocruz Vaccine ® against different variants of SARS-COV-2 in Botucatu-SP

Study of the Effectiveness of the COVID-19 Recombinante/Fiocruz Vaccine ® against different variants of SARS-COV-2 in the municipality of Botucatu-SP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-8yrrf9s
Enrollment
Unknown
Registered
2021-06-30
Start date
2021-05-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Swab collection (examination for RNA research of SARS-CoV-2, by the RT-PCR method) from aprox. 10.000 volunteers. The monitoring of those included for the occurrence of hospitalization and death will
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3965

Sponsors

Universidade Estadual Paulista "Júlio de Mesquita Filho" (UNESP) - Faculdade de Medicina de Botucatu (FMB)
Lead Sponsor
Bill And Melinda Gates Foundation
Collaborator

Eligibility

Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: Residents of Botucatu aged between 18 and 65 years. This population is estimated to be 81.472 individuals. Residents of Polo Cuesta aged between 18-65 years. Suspected to have SARS-CoV2 symptomatic infection and eligible as per case ascertainment guideline of the municipality for RT-PCR swab. Informed consent prior to swabbing. Children and adolescents (all non-vaccinated) from both communities will be included for the assessment of herd immunity. Informed consent of parents or guardians will be required.

Exclusion criteria

Exclusion criteria: Non-residents of Botucatu and healthy individuals

Design outcomes

Primary

MeasureTime frame
Effectiveness of 1 dose of recombinant Covid vaccine Fiocruz to protect against any laboratory confirmed Covid 19 disease caused by any strain as of 3 weeks post dose 1.;Effectiveness of recombinant Covid vaccine Fiocruz to protect against any laboratory confirmed Covid 19 disease caused by any strain after full vaccination (2 weeks after dose 2). ;Effectiveness of recombinant Covid vaccine Fiocruz to protect against any laboratory confirmed Covid 19 disease caused by the P1 variant after full vaccination (2 weeks after dose 2).;Effectiveness of 1 dose of recombinant Covid vaccine Fiocruz to protect against any laboratory confirmed Covid 19 disease caused by the P1 variant as of 3 weeks post dose 1.—

Secondary

MeasureTime frame
Effectiveness of recombinant Covid vaccine Fiocruz as of 3 weeks after dose 1 and 2 weeks after dose 2 to protect against severe clinical disease caused by any strain/ P1 variant.—

Countries

Brazil

Contacts

Public ContactCarlos Fortaleza

Faculdade de Medicina de Botucatu

carlos.fortaleza@unesp.br+55(14)3880-1284

Outcome results

None listed

Source: REBEC (via WHO ICTRP)