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Completed

NCT Number: NCT04974164

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gral Esp Ntra Sra dela Alt, Higuamo, La Altagracia Province, Dominican Republic

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About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Inactivated Covid-19 vaccine

Biological

Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen

Other names: CoronaVac

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. To profile the circulating strains of SARS-CoV-2 in DR

    Time frame: Day 14 after the second dose

    Circulating strains of SARS-CoV-2 in DR

Sponsors and collaborators

Lead sponsor

Sinovac Research and Development Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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