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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974164
• Other study ID #: CoronaVacTND
• Status: Completed
• Start date: August 17, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: August 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: December 13, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Inactivated COVID-19 Vaccine
Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen

Locations

Country	Name	City	State
Dominican Republic	Moscoso Puello Hospital	Bella Vista	Distrito Nacional
Dominican Republic	Gral Esp Ntra Sra dela Alt	Higuamo	La Altagracia
Dominican Republic	Hospital IMG	Higuey	La Altagracia
Dominican Republic	Fuerza AéreaDr Ramón Lara	Los Alcarrizos	Santo Domingo
Dominican Republic	JoséM.Cabral V Báez	Puñal	Santiago
Dominican Republic	Marcelino Vélez Santana	San Antonio de Guerra	Santo Domingo
Dominican Republic	Centro Médico Bournigal	San Felipe de Puerto Plata	Puerto Plata
Dominican Republic	Clinica Unión Medica del Norte	Santiago de los Caballeros	Santiago
Dominican Republic	Ricardo Limardo	Sosúa	Puerto Plata
Dominican Republic	Felix Maria Goico Hospital	Villa Francisca	Distrito Nacional

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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