Multicenter, Phase 3, Randomized Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against SARS-CoV-2 Infection in Adults.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Pontificia Universidad Catolica de Chile
- Enrollment
- 2300
- Locations
- 1
- Primary Endpoint
- Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults over 18 years of age.
- •Demonstrate the capacity to understand and sign the Informed Consent document.
- •Agree to comply with the study procedures and visits.
Exclusion Criteria
- •History of confirmed symptomatic SARS CoV-2 infection.
- •Pregnant (confirmed by positive urine pregnancy test) or breastfeeding females, and/or expressing intention to have sexual practices with reproductive potential without using contraceptive methods in the three months following vaccination.
- •History of an allergic reaction to the vaccine or components of the study vaccine or placebo.
- •Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic, or renal disease, according to anamnesis or physical examination; Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease.
- •Diseases that impair the immune system including neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies, and uncontrolled autoimmune diseases not controlled according to anamnesis or physical examination.
- •Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his medical representative, affects the participant's ability to understand and collaborate with the requirements of the study protocol.
- •Use of immunosuppressive therapies six months before inclusion in the study or its scheduled use within two years of inclusion. Immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, among others.
- •Have received an immunosuppressive dose of corticosteroids in the last three months before inclusion in the study or scheduled administration of an immunosuppressive dose of corticosteroids for the three months following inclusion in the study. The dose of corticosteroids considered immunosuppressive is equivalent to prednisone at a dose of 20 mg/day for adults for more than a week. The continuous use of topical or nasal corticosteroids is not considered immunosuppressive.
- •History of asplenia, either anatomic or functional.
- •History of bleeding disorders, as deficiency of clotting factors, coagulopathy, platelet dysfunction, or previous history of bleeding or significant bruising after IM injection or venipuncture.
Outcomes
Primary Outcomes
Incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule.
Time Frame: Two weeks after second dose up to one year after first dose
Vaccine efficacy to prevent virologically confirmed COVID-19 two weeks after the second dose of each vaccination schedule will be determined
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).
Time Frame: During the first 7 days after each dose of vaccine
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).
Secondary Outcomes
- Percentage of participants with a significant increase of anti-SARS-CoV-2 antibodies, determined by ELISA(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(Since first dose up to 4 weeks after second 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)(Four weeks after each dose of vaccine in two vaccination schedules)
- Incidence of hospitalized cases of COVID-19 two weeks after the second vaccination of two vaccination schedules(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(Since two weeks after the second dose up 12 month after first dose)
- Frequency of severe COVID-19 cases in participants who received at least one dose of vaccine in two vaccination schedules(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(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(Since first dose up to 4 weeks after second dose)