NCT04640402

A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 960 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen	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.
BIOLOGICAL	Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen	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.
BIOLOGICAL	High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen	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.
BIOLOGICAL	High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen	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.
BIOLOGICAL	Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen	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.
BIOLOGICAL	Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen	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.
BIOLOGICAL	High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen	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.
BIOLOGICAL	High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen	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.
BIOLOGICAL	Low-dose placebo (18-59 years) & Two dose regimen	18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
BIOLOGICAL	Low-dose placebo (18-59 years) & Three dose regimen	18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
BIOLOGICAL	High-dose placebo (18-59 years) & Two dose regimen	18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
BIOLOGICAL	High-dose placebo (18-59 years) & Three dose regimen	18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
BIOLOGICAL	Low-dose placebo (60-85 years) & Two dose regimen	60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
BIOLOGICAL	Low-dose placebo (60-85 years) & Three dose regimen	60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
BIOLOGICAL	High-dose placebo (60-85 years) & Two dose regimen	60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
BIOLOGICAL	High-dose placebo (60-85 years) & Three dose regimen	60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.

Timeline

• Start date: 2020-11-17
• Primary completion: 2021-02-18
• Completion: 2021-11-23
• First posted: 2020-11-23
• Last updated: 2022-06-01

Locations

1 site across 1 country: China