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

Completed

• Conditions: COVID-19
• Interventions: Biological: Inactivated COVID-19 Vaccine

• Registration Number: NCT04974164
• Lead Sponsor: Sinovac Research and Development Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Status Verified: 2021-08
• Study Start: 2021-08-17
• Primary Completion: 2021-10-17
• Study Completion: 2021-12-13
• Last Update Submitted: 2022-08-21
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinic controls group	Inactivated COVID-19 Vaccine	Those with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700)
Clinic cases group	Inactivated COVID-19 Vaccine	Those with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700)

Primary Outcome Measures

Name	Time	Method
Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections	Day 14 after the second dose	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
Protective effectiveness of complete vaccination of CoronaVac against COVID-19 hospitalizations and severe cases.	Day 14 after the second dose	Severe disease (including death), defined as a score \>5 in terms of WHO clinical progression scale due to SARS-CoV-2 infection

Secondary Outcome Measures

Name	Time	Method
To profile the circulating strains of SARS-CoV-2 in DR	Day 14 after the second dose	Circulating strains of SARS-CoV-2 in DR

Trial Locations

Locations (10)

Centro Médico Bournigal; 🇩🇴 San Felipe de Puerto Plata, Puerto Plata, Dominican Republic

Felix Maria Goico Hospital; 🇩🇴 Villa Francisca, Distrito Nacional, Dominican Republic

JoséM.Cabral V Báez; 🇩🇴 Puñal, Santiago, Dominican Republic

Moscoso Puello Hospital; 🇩🇴 Bella Vista, Distrito Nacional, Dominican Republic

Clinica Unión Medica del Norte; 🇩🇴 Santiago de los Caballeros, Santiago, Dominican Republic

Hospital IMG; 🇩🇴 Higuey, La Altagracia, Dominican Republic

Fuerza AéreaDr Ramón Lara; 🇩🇴 Los Alcarrizos, Santo Domingo, Dominican Republic

Marcelino Vélez Santana; 🇩🇴 San Antonio de Guerra, Santo Domingo, Dominican Republic

Gral Esp Ntra Sra dela Alt; 🇩🇴 Higuamo, La Altagracia, Dominican Republic

Ricardo Limardo; 🇩🇴 Sosúa, Puerto Plata, Dominican Republic