NCT04813562

Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

A Single-center, Randomized, Double Blinded, Placebo Controlled, Phase 2 Clinical Trial of Recombinant COVID-19 Vaccine (CHO Cells), in the Subjects From Healthy Aged 18 Years and Above

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• 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, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).

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 (CHO 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 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) 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, 480 in total. Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56	18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
BIOLOGICAL	a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56	18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
BIOLOGICAL	a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56	60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
BIOLOGICAL	a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56	60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
BIOLOGICAL	a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56	18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
BIOLOGICAL	a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56	18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
BIOLOGICAL	a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56	60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
BIOLOGICAL	a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56	60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2021-03-24
• Last updated: 2022-03-31

Locations

1 site across 1 country: China