Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic

Sinovac Research and Development Co., Ltd.1,400 enrolled

Overview

This study is a multisite ,grouped test-negative case-control , phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to estimate the protective effectiveness of complete vaccination (measured ≥14 days after the second dose) of CoronaVac against symptomatic SARS-COV-2 infections ,COVID-19 hospitalizations and severe cases.

This study is a multisite,grouped test-negative case-control , phase Ⅳ clinical trial in population aged 18 years and older. The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in ten (10) selected hospitals and their catchment communities in five provinces of the Dominican Republic (DR): National District, La Altagracia, Puerto Plata, Santiago, and Santo Domingo from July 1, 2021 to April 30, 2022 . A total of 1400 subjects will be enrolled with 700 estimated clinic cases who are diagnosed as SARS-CoV-2 infection by real-time polymerase chain reaction (RT-PCR); and 700 estimated clinic controls who have a negative RT-PCR test.And subjects will receive two doses of vaccine for primary immunization .

Study Type

OBSERVATIONAL

Enrollment

1,400

Conditions

COVID-19

Interventions

Inactivated COVID-19 VaccineBIOLOGICAL

Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged ≥18 years; * Permanent residents of study provinces; * Able and willing to provide informed consent to participate in the study; * Able and willing to provide nasopharyngeal swab and venous blood sample; * Able and willing to complete a questionnaire survey for collecting information on histories of COVID-19 vaccination and disease; * Considered as suspected cases of SARS-CoV-2 infections by the physicians in the study clinics according to DR national protocol. Exclusion Criteria: \-

Locations (10)

Gral Esp Ntra Sra dela Alt

Higuamo, La Altagracia Province, Dominican Republic

Hospital IMG

Salvaleón de Higüey, La Altagracia Province, Dominican Republic

Moscoso Puello Hospital

Bella Vista, Nacional, Dominican Republic

Outcomes

Primary Outcomes

Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections

SARS-COV-2 infections confirmed by real-time polymerase chain reaction (RT-PCR) in newly collected nasopharyngeal swab sample among patients visiting the ER in the study hospitals during the study period without a positive RT-PCR test in the preceding 90 days period

Time frame: Day 14 after the second dose

Protective effectiveness of complete vaccination of CoronaVac against COVID-19 hospitalizations and severe cases.

Severe disease (including death), defined as a score \>5 in terms of WHO clinical progression scale due to SARS-CoV-2 infection

Time frame: Day 14 after the second dose

Secondary Outcomes

To profile the circulating strains of SARS-CoV-2 in DR

Circulating strains of SARS-CoV-2 in DR

Time frame: Day 14 after the second dose

Data from ClinicalTrials.gov

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