NCT04718467

Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)

A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.

Detailed description

This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 vaccine (Sf9 cells)	Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
BIOLOGICAL	Placebo	Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-15
• Completion: 2022-03-15
• First posted: 2021-01-22
• Last updated: 2021-05-25

Locations

1 site across 1 country: China