Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic
1 other identifier
observational
1,400
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
August 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedAugust 23, 2022
August 1, 2021
2 months
July 22, 2021
August 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
To profile the circulating strains of SARS-CoV-2 in DR
Day 14 after the second dose
Study Arms (2)
Clinic cases group
Those with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700)
Clinic controls group
Those with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700)
Interventions
Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen
Eligibility Criteria
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Gral Esp Ntra Sra dela Alt
Higuamo, La Altagracia Province, Dominican Republic
Hospital IMG
Salvaleón de Higüey, La Altagracia Province, Dominican Republic
Moscoso Puello Hospital
Bella Vista, Nacional, Dominican Republic
Felix Maria Goico Hospital
Villa Francisca, Nacional, Dominican Republic
Centro Médico Bournigal
Puerto Plata, Puerto Plata, Dominican Republic
Ricardo Limardo
Sosua, Cabarete, Puerto Plata, Dominican Republic
JoséM.Cabral V Báez
Puñal, Santiago Province, Dominican Republic
Clinica Unión Medica del Norte
Santiago de los Caballeros, Santiago Province, Dominican Republic
Marcelino Vélez Santana
Guerra, Santo Domingo Province, Dominican Republic
Fuerza AéreaDr Ramón Lara
Los Alcarrizos, Santo Domingo Province, Dominican Republic
Biospecimen
All laboratory antibody and RT-PCR tests will be conducted in the central study lab (Laboratorio de Referencia) in the capital city.Antibody testing on the blood sample will be performed to test anti-SARS-CoV-2 IgGantibody,the remaining serum will be stored in -70℃ (or -40℃) freezer；RT-PCR testing on nasopharyngeal swab will be performed to assess the presence of SARS-CoV-2 RNA；SARS-CoV-2 sequencing testing，the remaining swab for PCR testing will be stored in -70oC (or -40oC) freezer for SARS-CoV-2 sequencing testing to assess protection against variants when the test is available.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eddy Perez-Then, Doctor
Ministry of Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2021
First Posted
July 23, 2021
Study Start
August 17, 2021
Primary Completion
October 17, 2021
Study Completion
December 13, 2021
Last Updated
August 23, 2022
Record last verified: 2021-08