Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05367895
• Other study ID #: EFFERVESCENCE/ BRAZIL
• Status: Active, not recruiting
• Start date: July 30, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: April 2022
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective test-negative case-control study of COVID-19 Vaccine (CoronaVac®) manufactured 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.

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): 1. VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2. 2. E-SUS, mandatory report database for mild to moderate COVID-19. 3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14000
• Est. completion date: February 15, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• COVID-19 Vaccine (Vero Cell), Inactivated
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.

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)	Manguinhos

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	vaccine effectiveness of homologous booster-dose vaccination	To compare vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® in periods with predominance of Delta and Omicron SARS-CoV-2 variants	6 months after the third dose of COVID-19 vaccine
Other	help support the approval of new indication (i.e. boosters) of the CoronaVac®.	To generate data to help support the approval of new indication (i.e. boosters) of the CoronaVac®.	6 months after the third dose of COVID-19 vaccine
Other	support post-approval study requirements of CoronaVac®.	To support post-approval study requirements of CoronaVac®.	6 months after the third dose of COVID-19 vaccine
Primary	Effectiveness of homologous booster-dose vaccination with CoronaVac®	To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease	6 months after the third dose of COVID-19 vaccine
Secondary	effectiveness of homologous booster-dose vaccination with CoronaVac®	To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 hospital admissions	6 months after the third dose of COVID-19 vaccine
Secondary	vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®	To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit admissions.	6 months after the third dose of COVID-19 vaccine
Secondary	Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®	To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit deaths.	6 months after the third dose of COVID-19 vaccine