COVID-19NCT04974164
Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic
An observational study of COVID-19, run by Sinovac Research and Development Co., Ltd. at 10 sites in Dominican Republic.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Inactivated COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 1,400 participants
- Where
- 10 sitesDominican Republic
- Study dates
- 17 Aug 2021to 13 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Dominican Republic10 sites
Moscoso Puello Hospital
Bella Vista, Nacional
Marcelino Vélez Santana
Guerra, Santo Domingo Province
Gral Esp Ntra Sra dela Alt
Higuamo, La Altagracia Province
Fuerza AéreaDr Ramón Lara
Los Alcarrizos, Santo Domingo Province
Centro Médico Bournigal
Puerto Plata, Puerto Plata
JoséM.Cabral V Báez
Puñal, Santiago Province
Hospital IMG
Salvaleón de Higüey, La Altagracia Province
Clinica Unión Medica del Norte
Santiago de los Caballeros, Santiago Province
Ricardo Limardo
Sosua, Cabarete, Puerto Plata
Felix Maria Goico Hospital
Villa Francisca, Nacional
About this study
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
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.
Read the 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 .
- Conditions
- COVID-19
- Being tested
- Inactivated COVID-19 Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated COVID-19 VaccineBiological
Also called CoronaVac
Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen
| Study group | Role | What they receive |
|---|---|---|
| Clinic cases group | Those with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700) Receives: Biological: Inactivated COVID-19 Vaccine | |
| Clinic controls group | Those with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700) Receives: Biological: Inactivated COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 14 after the second dose
Secondary outcomes (1)
To profile the circulating strains of SARS-CoV-2 in DR
Circulating strains of SARS-CoV-2 in DR
Measured: Day 14 after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start17 Aug 2021
- Primary completion17 Oct 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Research and Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eddy Perez-Then, Doctor, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974164
- Sponsor's protocol ID
- CoronaVacTND
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04974164
- Acronym / sponsor ID
- CoronaVacTND
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic cases group | – | Biological: Inactivated COVID-19 VaccineThose with a positive RT-PCR test will be the test-positive cases or clinic cases (approximate N=700) |
| Clinic controls group | – | Biological: Inactivated COVID-19 VaccineThose with a negative RT-PCR test will be the test-negative cases or clinic controls (N=700) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated COVID-19 VaccineAlso: CoronaVacEach vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen | Biological | Clinic cases group, Clinic controls group |
Primary outcome
Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections
Time frame: 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.
Time frame: 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
1 secondary outcome
To profile the circulating strains of SARS-CoV-2 in DR
Time frame: Day 14 after the second dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddy Perez-Then, Doctor principal investigator
Ministry of Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Sinovac Research and Development Co., Ltd. at 10 sites in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections (time frame: Day 14 after the second dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.