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

NCT05367895 | Unknown

• 1 other identifier: EFFERVESCENCE/ BRAZIL
• Study Type: observational
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• effectiveness of homologous booster-dose vaccination with CoronaVac®

  6 months after the third dose of COVID-19 vaccine

• vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®

  6 months after the third dose of COVID-19 vaccine

• Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®

  6 months after the third dose of COVID-19 vaccine

Other Outcomes (3)

• vaccine effectiveness of homologous booster-dose vaccination

  6 months after the third dose of COVID-19 vaccine

• help support the approval of new indication (i.e. boosters) of the CoronaVac®.

  6 months after the third dose of COVID-19 vaccine

• support post-approval study requirements of CoronaVac®.

  6 months after the third dose of COVID-19 vaccine

Study Arms (4)

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.

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

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.

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

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.

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

Interventions

COVID-19 Vaccine (Vero Cell), Inactivated BIOLOGICAL

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.

Also known as: CoronaVac®

Exposure group 1; Exposure group 2; Non-Exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is community-dwelling individuals aged 18 years and above with no contra-indication for COVID-19 vaccination who consult a participating general practitioner or a hospital in São Paulo city, Brazil if they develop illness of interests (i.e., WHO definition of suspected COVID-19 cases) and had RT-PCR for SARS-Cov-2 colleceted.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (1)

Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)

Manguinhos, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The samples without DNA. Only data will be recovered from three health surveillance information electronic health records: 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.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; sinovac COVID-19 vaccine

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)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• André Machado amsiqueira@gmail.com, Doctor

  amsiqueira@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 10, 2022
• Study Start: July 30, 2022
• Primary Completion: August 15, 2022
• Study Completion: February 15, 2023
• Last Updated: January 12, 2023

Record last verified: 2022-04

Locations

BR (1)