NCT05408312

Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

Phase I Clinical Trial of Safety, Tolerance and Immunogenicity of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Experimental Vaccine 1	Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICAL	Experimental Vaccine 2	Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICAL	Experimental Vaccine 3	Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICAL	placebo	Intramuscular injection of low-dose Recombinant placebo in the deltoid muscle of the upper arm

Timeline

• Start date: 2022-06-18
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2022-06-07
• Last updated: 2026-01-16

Locations

1 site across 1 country: China