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

Sinovac

Status: Completed

Conditions: COVID-19

Treatments: Biological: Inactivated COVID-19 Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT04974164

CoronaVacTND

Details and patient eligibility

About

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.

Full description

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 .

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,400 participants in 2 patient groups

Clinic cases group

Description:

Those with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700)

Treatment:

Biological: Inactivated COVID-19 Vaccine

Clinic controls group

Description:

Those with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700)

Treatment:

Biological: Inactivated COVID-19 Vaccine