Clinical trial NCT04974164: Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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 .

Eligibility criteria: 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:

-

Primary outcomes:
measure: Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections
timeFrame: Day 14 after the second dose
measure: Protective effectiveness of complete vaccination of CoronaVac against COVID-19 hospitalizations and severe cases.
timeFrame: Day 14 after the second dose
Secondary outcomes:
measure: To profile the circulating strains of SARS-CoV-2 in DR
timeFrame: Day 14 after the second dose
Other outcomes:
Locations:
city: Bella Vista
country: Dominican Republic
facility: Moscoso Puello Hospital
state: Distrito Nacional
city: Villa Francisca
country: Dominican Republic
facility: Felix Maria Goico Hospital
state: Distrito Nacional
city: Higuamo
country: Dominican Republic
facility: Gral Esp Ntra Sra dela Alt
state: La Altagracia
city: Higuey
country: Dominican Republic
facility: Hospital IMG
state: La Altagracia
city: San Felipe de Puerto Plata
country: Dominican Republic
facility: Centro Médico Bournigal
state: Puerto Plata
city: Sosúa
country: Dominican Republic
facility: Ricardo Limardo
state: Puerto Plata
city: Puñal
country: Dominican Republic
facility: JoséM.Cabral V Báez
state: Santiago
city: Santiago de los Caballeros
country: Dominican Republic
facility: Clinica Unión Medica del Norte
state: Santiago
city: Los Alcarrizos
country: Dominican Republic
facility: Fuerza AéreaDr Ramón Lara
state: Santo Domingo
city: San Antonio de Guerra
country: Dominican Republic
facility: Marcelino Vélez Santana
state: Santo Domingo
Study officials:
affiliation: Ministry of Health
name: Eddy Perez-Then, Doctor
role: PRINCIPAL_INVESTIGATOR
References: