NCT04869592

A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19

Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3,100 (actual)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

phase I study will evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 3 years and older. 300 subjects will be enrolled and divided into 5 age groups: 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group and 3-8 years old group. In each group, there are two regimen cohort: low-dose at 0,30, 60 schedule and high-dose at 0,30,60 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1. Phase II clinical study will explore dose and immunization procedures in 5 age groups, including 18-59 years old group, 60-69 years old group, ≥70 years old group, 9-17 years old group, and 3-8 years old group, with a total of 3280 subjects.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)	Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
BIOLOGICAL	high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)	Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
BIOLOGICAL	placebo	Intramuscular injection of placebo in the deltoid muscle of the upper arm

Timeline

• Start date: 2021-04-25
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2021-05-03
• Last updated: 2026-01-16

Locations

1 site across 1 country: China