Protein in vaccine trial#

Results In cohort 1 a total 17 319 individuals received 2 doses and in cohreceived 3 doses of the vaccine or placebo. Intention-to-treat analysis was performed. Other outcomes were adverse events and severe COVID-19. Main Outcomes and Measures The primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Vaccinations were administered via intramuscular injection. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Interventions In cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. The study was conducted from April 26 to September 25, 2021. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment.

Protein in vaccine trial#

Objective To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults.ĭesign, Setting, and Participants A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Importance The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown.

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Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.Percentage of Different SARS-CoV-2 Variants of Concern During the Study Reason for Unmet Inclusion Criteria in Screened ParticipantsĮFigure 4. The Number Needed to Vaccinate in Cohort 1 and Cohort 2ĮTable 10. Serious and Medically Attended Adverse Events by MedDRA System Organ Class During the Study, in Randomized Participants Who Received at Least One DoseĮTable 9. Serious and Medically Attended Adverse Events (SAEs) From Day 0 Up to Day 120ĮTable 8. Local and Systemic Adverse Events After Injection of the First, Second and Third DosesĮTable 7. Adverse Events (AEs) From Day 0 to Day 28ĮTable 6. Seroconversion Rate in Different Subgroups After the First, Second, and Third DosesĮTable 5. Humoral Immune Response (Anti SARS-CoV-2 S1 IgG and Neutralizing Antibodies Titers) in the Vaccine and Placebo GroupsĮTable 4. Vaccine Efficacy Against SARS-CoV-2 in Different Subgroups Based on Logistic RegressionĮFigure 3.

Vaccine Efficacy Against SARS-CoV-2 Using the Logistic ModelĮTable 3. Vaccine Efficacy Against SARS-CoV-2 14 Days in Different Subgroups Based on Stratified Cox RegressionĮTable 2. Schoenfeld Residual Plots and Estimated Log-Log Survival Curves for Assessing the Proportional Hazard AssumptionĮTable 1. List of Participating Sites and Address of Different Units Within Each CityĮFigure 2.

Study Sites of the SOBERANA trial in IranĮAppendix.