COVID-19 Clinical Trial
Official title:
A Randomized, Open, Positive Controlled Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) in People Aged 18 Years and Over
Popular topic:A Clinical Study of Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell) Overall design:The study was designed as a randomized, open and controlled study. Study population: People aged 18 years and above and 6-15 months after the completion of basic immunization or 6-9 months after the completion of enhanced immunization with the new coronal prototype vaccine. Test groups:Study group；Control group；Observation group ①；Observation group ②
Research topic: A randomized, open, positive controlled clinical study to evaluate the immunogenicity and safety of the recombinant novel coronavirus protein vaccine (CHO cell) of Omicron-Delta strain in people aged 18 years and above. Product name:Recombinant Omicron-Delta COVID-19 Vaccine (CHO Cell),each dose contains 25μg DO-RBD protein/0.5mL/bottle. Indications: Prevention of respiratory diseases caused by new coronavirus infection. Research purpose: Main purpose:To evaluate the immunogenicity of Omicron Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against new crown variants (Delta, Omicron BA. 2，Omicron BA. 5) in people aged 18 years and above. Secondary objectives: To evaluate the safety of recombinant novel coronavirus protein vaccine (CHO cells) of Omicron Delta strain in people aged 18 years and above. Research design:The study adopted a randomized, open and controlled design. Study group and control group: 150 patients who completed the basic immunization with inactivated new crown vaccine were randomly divided into study group and control group, and were injected with study vaccine and control vaccine respectively; Observation group ①: 75 patients who completed homologous booster immunization with inactivated new coronal vaccine were injected with one dose of study vaccine; Observation group ②: 75 patients who completed the basic immunization of new coronal recombinant vaccine were injected with one dose of study vaccine. Safety endpoint: 1. Incidence of all AEs occurring within 28 days after vaccination:(1)Total incidence of AEs;(2) Incidence of AEs associated with the investigational vaccine;(3) Incidence of AEs of Grade 3 or above;(4) Incidence of AEs associated with the investigational vaccine of Grade 3 or above;(5) Incidence of AEs resulting in withdrawal;(6)Incidence of AEs resulting in withdrawal that are associated with the investigational vaccine; 2. Incidence of all serious adverse events (SAEs) within six months after vaccination, and incidence of vaccine-related SAEs. Immunogenicity endpoint: 1. Primary end point: GMT of neutralizing antibody in the serum of subjects against the SARS-CoV-2 Delta, BA.2, and BA.5 within 14 days after vaccination. 2. Secondary end points:GMT of neutralizing antibody in the serum of subjects of the study group and the control group against SARS-CoV-2 Delta, BA.2, BA. 5 within six months after vaccination. ;
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