A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to
      evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the
      subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85
      years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses
      (20μg/40μg).
    

Detailed description: 
      This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to
      evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the
      subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85
      years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization
      procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages
      group (adults and elder): Each group including 120 participants. Vaccination or placebo group
      will be randomly assigned to receive in a 5:1 ratio, 960 in total.
    

Intervention name(s): Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen; Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen; High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen; High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen; Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen; Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen; High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen; High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen; Low-dose placebo (18-59 years) & Two dose regimen; Low-dose placebo (18-59 years) & Three dose regimen; High-dose placebo (18-59 years) & Two dose regimen; High-dose placebo (18-59 years) & Three dose regimen; Low-dose placebo (60-85 years) & Two dose regimen; Low-dose placebo (60-85 years) & Three dose regimen; High-dose placebo (60-85 years) & Two dose regimen; High-dose placebo (60-85 years) & Three dose regimen
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.; 18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.; 18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.; 18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.; 60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.; 60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.; 60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.; 60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.; 18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.; 18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.; 18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.; 18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.; 60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.; 60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.; 60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.; 60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; COVID-19 Vaccine; Recombinant vaccine