The study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. Two doses of the vaccine will be administered in a 0,14 and a 0,28-day schedule. Follow-up of safety and efficacy will be assessed for 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.
This study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. This study will be performed in 8 centers. Two schedules will be compared: 0,14 and 0,28-day, at a 1:1 rate. 40% of participants will be 60 or more years-old. Follow-up of safety and efficacy will be assessed for 12 months after administering the first dose. The collection of the data will be through an electronic Case Report Form. Immunogenicity will be studied in a subgroup of participants. Initially, 2,300 volunteers will be recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,300
The vaccine contains inactivated SARS-CoV-2 virus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.The final product will be supplied in a pre-filled syringe containing 0.5 ml of solution for injection that corresponds to a dose of the vaccine.
Centro de Especialidades Médicas, Red de Salud UC Christus
Santiago, RM, Chile
Frequency of solicited and unsolicited adverse events that occur during the period of one week after each dose of the vaccine in two vaccination schedules: 0,14 and 0,28 days stratified by age group (18-59 years, and 60 or more years).
The frequency of solicited and unsolicited local and systemic adverse reactions will be registered. This will be measured during the first 7 days after each vaccination. These adverse reactions will be registered according to the age group in adults (18-59 years old) and the elderly (60 years of age or older).
Time frame: During the first 7 days after each dose of vaccine
Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule.
Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule will be determined
Time frame: Two weeks after second dose up to one year after first dose
Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules
The incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules will be determined.
Time frame: Since two weeks after the second dose of two vaccination schedules and up 12 month after first dose
Incidence of severe cases or deaths of COVID-19 virologically confirmed two weeks after the second vaccination of two vaccination schedules
The incidence of severe cases of COVID-19 and deaths, confirmed through PCR, two weeks after the second vaccination of two vaccination schedules, will be determined.
Time frame: Since two weeks after the second dose up 12 month after first dose
Incidence of adverse reactions to the vaccine, local and systemic, solicited and unsolicited, within the period of four weeks after each vaccination of two vaccination schedules, according to the age, adults (18-59 years old) and elder (>60 years)
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The incidence of adverse reactions to the vaccine, both local and systemic, solicited and unsolicited will be determined. These adverse reactions will be measured within the period of four weeks after each dose of vaccination of two vaccination schedules. These adverse reactions will be registered according to the age group in adult (18-59 years old) and elder (60 years of age or older) subjects
Time frame: Four weeks after each dose of vaccine in two vaccination schedules
Frequency of severe COVID-19 cases in participants who received at least one dose of vaccine in two vaccination schedules
The frequency of severe COVID-19 cases in participants who received at least one dose of vaccine in two vaccination schedules will be determined.
Time frame: Since first dose up to 12 month after
Incidence of serious adverse events (SAE) and adverse events in participants who have received at least one dose of the vaccine, in two vaccination schedules
The occurrence of serious adverse events (SAE) and adverse events of special interest in participants who have received at least one dose of the vaccine in two vaccination schedules, will be determined
Time frame: Since first dose up to 12 month after
Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, in two vaccination schedules, determined by flow Cytometry and ELISPOT
The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, in two vaccination schedules will be evaluated
Time frame: Since first dose up to 4 weeks after second dose
Percentage of participants with a significant increase of anti-SARS-CoV-2 antibodies, determined by ELISA
The presence of anti-SARS-CoV-2 antibodies in a subgroup of participants, before and two weeks after the administration of each dose of the vaccine, in two vaccination schedules, will be evaluated.
Time frame: Since first dose up to 2 weeks after second dose
Percentage of participants that show a significant increase in SARS-CoV-2 specific T cells after vaccination, determined by flow Cytometry and ELISPOT
The cellular immune response in a subgroup of participants, before and two and four weeks after the administration of each dose of the vaccine, will be evaluated.
Time frame: Since first dose up to 4 weeks after second dose