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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Effectiveness of COVID-19 Vaccine (Vero Cell), Inactivated (CoronaVac) for Preventing Symptomatic SARS-CoV-2 Infections and Hospitalizations in the Dominican Republic - Test-Negative Case-Control Study

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Inactivated COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinic cases group<br>Those with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700) | Biological: Inactivated COVID-19 Vaccine<br>* Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen<br>* Other names: CoronaVac;|
| Clinic controls group<br>Those with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700) | Biological: Inactivated COVID-19 Vaccine<br>* Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen<br>* Other names: CoronaVac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Day 14 after the second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To profile the circulating strains of SARS-CoV-2 in DR | Circulating strains of SARS-CoV-2 in DR | Day 14 after the second dose |