NCT06113731

A PhaseⅡ Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine

A Randomized, Blinded, Controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a COVID-19 mRNA Vaccine (ZSVG-02-O) in a Healthy Population 18 Years of Age and Older

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 980 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.

Detailed description

This study uses a randomized, blinded and controlled design, with age stratification of 18-59 years and ≥60 years , including the test vaccine at different doses (30 μg and 60 μg) and an active control vaccine. A total of 980 subjects will be enrolled in this study. 490 subjects aged 18-59 years will be randomly assigned to cohort A1 (test vaccine dose 1), A2 (test vaccine dose 2) and A3 (control vaccine) for the 2-dose regimen (0,28-day) and to cohort A4 (test vaccine dose 1), A5 (test vaccine dose 2) and A6 (active control) for the 1-dose regimen in a ratio of 3:3:1:3:3:1. Another 490 subjects aged 60 years or older will be randomized to cohort B1 (test vaccine dose 1), B2 (test vaccine dose 2) and B3 (active control) for the 2-dose regimen (0,28-day), and cohort B4 (test vaccine dose 1), B5 (test vaccine dose 2) and B6 (control vaccine) for the 1-dose regimen in a ratio of 3:3:1:3:3:1.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 mRNA Vaccine (ZSVG-02-O)	30 μg
BIOLOGICAL	COVID-19 mRNA Vaccine (ZSVG-02-O)	60 μg
BIOLOGICAL	COVID-19 Vaccine (Vero Cell) ,Inactivated	COVILO

Timeline

• Start date: 2023-07-10
• Primary completion: 2023-10-30
• Completion: 2024-10-01
• First posted: 2023-11-02
• Last updated: 2023-11-08

Locations

2 sites across 1 country: China