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

NCT ID: NCT04974164

Last Updated: 2022-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-17

Study Completion Date

2021-12-13

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.

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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 .

Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic cases group

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

Inactivated COVID-19 Vaccine

Intervention Type BIOLOGICAL

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

Clinic controls group

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

Inactivated COVID-19 Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Inactivated COVID-19 Vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

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CoronaVac

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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Research and Development Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eddy Perez-Then, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

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Gral Esp Ntra Sra dela Alt

Higuamo, La Altagracia Province, Dominican Republic

Site Status

Hospital IMG

Salvaleón de Higüey, La Altagracia Province, Dominican Republic

Site Status

Moscoso Puello Hospital

Bella Vista, Nacional, Dominican Republic

Site Status

Felix Maria Goico Hospital

Villa Francisca, Nacional, Dominican Republic

Site Status

Centro Médico Bournigal

Puerto Plata, Puerto Plata, Dominican Republic

Site Status

Ricardo Limardo

Sosua, Cabarete, Puerto Plata, Dominican Republic

Site Status

JoséM.Cabral V Báez

Puñal, Santiago Province, Dominican Republic

Site Status

Clinica Unión Medica del Norte

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status

Marcelino Vélez Santana

Guerra, Santo Domingo Province, Dominican Republic

Site Status

Fuerza AéreaDr Ramón Lara

Los Alcarrizos, Santo Domingo Province, Dominican Republic

Site Status

Countries

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Dominican Republic

Other Identifiers

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CoronaVacTND

Identifier Type: -

Identifier Source: org_study_id

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