Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose
Effectiveness of CoronaVac® First Booster Dose for Preventing Symptomatic Acute Respiratory Infection Caused by SARS-CoV-2 Virus in Adults in São Paulo City, Brazil: a Retrospective Test-negative Case-control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a retrospective test-negative case-control study in São Paulo city, Brazil . The COVID-19 Vaccine (CoronaVac® )produced by Sinovac Research and Development Co., Ltd.The main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease.A total of 14000 subjects will be enrolled,including 7,000 positive cases and 7,000 test negative COVID-19 cases The Statistical Analysis Plan (SAP) will include univariate (and, when required, multivariable) models of logistic regression.Data will be recovered from three health surveillance information electronic health records (EHRs):
- VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2.
- E-SUS, mandatory report database for mild to moderate COVID-19.
- SIVEP-GRIPE, mandatory report database for severe cases of COVID-19. All those RWD sources are available at the São Paulo Municipality Centers for Health Surveillance.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Manguinhos, Brazil
- Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Exposure group 1: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022 and received a three-dose homologous vaccination with CoronaVac. Specifically, ≥14 days after receipt of the third vaccine dose using a homologous regimen with CoronaVac.
- Exposure group 2: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received a two-dose vaccination with CoronaVac and did not receive any booster vaccine. Specifically, ≥14 days after receipt of the second vaccine dose and before the third dose of CoronaVac.
- Exposure group 3: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received only one dose vaccination with CoronaVac and did not receive any other vaccine dose. Specifically, ≥14 days after receipt of the first vaccine dose and before the second dose of CoronaVac.
- Non-Exposure group: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who were not vaccinated. No history of vaccination for any type of COVID-19 vaccine, or <14 days after receipt of the first vaccine of CoronaVac.
Exclusion Criteria:
- Anyone who received other vaccines for the first doses.
- Anyone who received CoronaVac for the two initial doses but other vaccines for the booster (heterologous immunization).
- Subjects with incomplete vaccination history.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Exposure group 1
Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022 and received a three-dose homologous vaccination with CoronaVac.
Specifically, ≥14 days after receipt of the third vaccine dose using a homologous regimen with CoronaVac.
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Form: CoronaVac® is a milky-white suspension. Stratified precipitate may form that can be dispersed by shaking. Presentation: Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen. Administration and schedule: Two doses with an interval of 21 days should be administered for primary immunization. 0.5 mL per dose. Route: IM in the deltoid region of the upper arm after shaking the vial well before use.
Other Names:
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Exposure group 2
Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received a two-dose vaccination with CoronaVac and did not receive any booster vaccine.
Specifically, ≥14 days after receipt of the second vaccine dose and before the third dose of CoronaVac.
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Form: CoronaVac® is a milky-white suspension. Stratified precipitate may form that can be dispersed by shaking. Presentation: Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen. Administration and schedule: Two doses with an interval of 21 days should be administered for primary immunization. 0.5 mL per dose. Route: IM in the deltoid region of the upper arm after shaking the vial well before use.
Other Names:
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Exposure group 3
Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received only one dose vaccination with CoronaVac and did not receive any other vaccine dose.
Specifically, ≥14 days after receipt of the first vaccine dose and before the second dose of CoronaVac.
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Non-Exposure group
Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who were not vaccinated.
No history of vaccination for any type of COVID-19 vaccine, or <14 days after receipt of the first vaccine of CoronaVac.
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Form: CoronaVac® is a milky-white suspension. Stratified precipitate may form that can be dispersed by shaking. Presentation: Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen. Administration and schedule: Two doses with an interval of 21 days should be administered for primary immunization. 0.5 mL per dose. Route: IM in the deltoid region of the upper arm after shaking the vial well before use.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effectiveness of homologous booster-dose vaccination with CoronaVac®
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease
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6 months after the third dose of COVID-19 vaccine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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effectiveness of homologous booster-dose vaccination with CoronaVac®
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 hospital admissions
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6 months after the third dose of COVID-19 vaccine
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vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit admissions.
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6 months after the third dose of COVID-19 vaccine
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Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit deaths.
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6 months after the third dose of COVID-19 vaccine
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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vaccine effectiveness of homologous booster-dose vaccination
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To compare vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® in periods with predominance of Delta and Omicron SARS-CoV-2 variants
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6 months after the third dose of COVID-19 vaccine
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help support the approval of new indication (i.e. boosters) of the CoronaVac®.
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To generate data to help support the approval of new indication (i.e.
boosters) of the CoronaVac®.
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6 months after the third dose of COVID-19 vaccine
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support post-approval study requirements of CoronaVac®.
Time Frame: 6 months after the third dose of COVID-19 vaccine
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To support post-approval study requirements of CoronaVac®.
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6 months after the third dose of COVID-19 vaccine
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Collaborators and Investigators
Investigators
- Principal Investigator: André Machado amsiqueira@gmail.com, Doctor, amsiqueira@gmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFFERVESCENCE/ BRAZIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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