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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Inactivated COVID-19 Vaccine

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 Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participants will be recruited from clinic patients in 10 study hospitals in five provinces. Patients who visit the emergency room (ER), fever or respiratory disease clinics to seek diagnosis or health care for severe acute respiratory infection symptoms or signs and are considered as suspected cases of SARS-CoV-2 based in DR national COVID-19 clinical guideline will be invited to participate in the study, and 1400 clinic participants will be enrolled, 140 from each hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Eddy Perez-Then, Doctor, Ministry of Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2021
• Primary Completion (ACTUAL): October 17, 2021
• Study Completion (ACTUAL): December 13, 2021

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (ACTUAL): July 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CoronaVacTND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No