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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine
Hospital Gloria D'Or - Hospitais Integrados da Gavea S/A
Rio de Janeiro, Brazil
D'Or Institute for Research and Education
Rio de Janeiro, Brazil
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
Time frame: 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).
Time frame: Two weeks after the second immunization
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
Time frame: 28 days after the second immunization
Frequency of severe adverse events
Frequency of severe adverse events after vaccination, attributed to the vaccine after causality assessment
Time frame: 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
Time frame: 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).
Time frame: At inclusion and 4 weeks after the second vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second vaccination