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| Name | Class |
|---|---|
| Butantan Institute | OTHER_GOV |
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This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months.
This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months. This study will assess safety and immunogenicity of the inactivated vaccine adsorbed against COVID-19 (CoronaVac) in a population of healthy individuals older than 18 years of age.
The estimated number of participants is 1200. Participants will be recruited within 3-4 months. The total duration of the study is estimated to be 30 months after recruitment begins.
The participants will remain in the study for approximately 24 months. The study will be carried out at the clinical research center of the D'Or Institute for Research and Education (IDOR) located at the Hospital Glória D'Or, in the city of Rio de Janeiro, RJ, Brazil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccination | Other | All participants will receive two doses of the inactivated adsorbed vaccine against COVID-19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adsorbed COVID-19 (inactivated) Vaccine | Biological | Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of local and systemic adverse reactions in the first 7 days after immunization | Frequency of solicited and unsolicited local and systemic adverse reactions in the first 7 days after vaccination per age group (18-59 years old and 60 years old or older), attributed to the vaccine after causality assessment | Seven days after each immunization |
| Seroconversion rates | Seroconversion rates in the second week after the second dose of the vaccine per age group (18-59 years and 60 years old or older). | Two weeks after the second immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse reactions up to 28 days after immunization | Frequency of unsolicited local and systemic adverse reactions up to 28 days after the second dose of the vaccine per age group (18-59 years old and 60 years old or older), attributed to the vaccine after causality assessment | 28 days after the second immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of confirmed cases of COVID-19 | Frequency of confirmed cases of COVID-19 per age group (18-59 years old and 60 years old or older) over 24 months. | Up to 24 months after inclusion |
| Frequency of SARS-CoV-2 variants of concern (VOC) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gloria D'Or - Hospitais Integrados da Gavea S/A | Rio de Janeiro | 22211-230 | Brazil | |||
| D'Or Institute for Research and Education |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Frequency of severe adverse events |
Frequency of severe adverse events after vaccination, attributed to the vaccine after causality assessment |
| Up to 12 months after first immunization |
| Frequency of adverse events of special interest | Frequency of adverse events of special interest after receiving, at least, one dose of the vaccine | Up to 12 months after first immunization |
| Cell-mediated immune response | Cell-mediated immune response at inclusion and four weeks after the second vaccination per age group (18-59 years old and 60 years old or older). | At inclusion and 4 weeks after the second vaccination |
| Frequency of detection of antibodies against SARS-CoV-2 | Frequency of detection of antibodies against SARS-CoV-2 at inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second dose of the vaccine against COVID-19. | At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second vaccination |
| Geometric mean titer of neutralizing antibodies | Geometric mean titer of neutralizing antibodies against SARS-CoV-2 at inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second dose of the vaccine against COVID-19. | At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second vaccination |
Frequency of SARS-CoV-2 variants of concern (VOC) in confirmed cases of COVID-19.
| Up to 24 months after inclusion |
| Humoral and cellular immune response | Humoral and cellular immune response in confirmed cases of COVID-19 | Up to 24 months after inclusion |
| Rio de Janeiro |
| 22281100 |
| Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |