NCT06113744

A Phase 1 Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine

A Randomised, Blinded, Parallel-controlled Phase 1 Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a COVID-19 mRNA Vaccine in Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

A randomised, blinded, parallel-controlled phase 1 clinical trial to evaluate the safety and preliminary immunogenicity of a COVID-19 mRNA vaccine in a healthy population aged 18 years and older, and to investigate immunisation doses.

Detailed description

The phase 1 clinical trial is conducted in a randomised, blinded, parallel-controlled design to assess the safety, immunogenicity and immune persistence. Subjects will be divided into two age groups (18-59 and ≧60 years of age), and within the groups, subjects will be subdivided into three dose groups (10 μg,30 μg and 60 μg). The immunisation procedure is divided into one-dose group and two-dose group (0, 28 days). The total sample size is 164 subjects. 12 subjects will be assigned to each group according to different age, dose and immunisation procedure, respectively. In addition, 20 subjects (10 aged 18-59 years and 10 aged ≧60 years) will be enrolled as active control and vaccinated with 2 doses of inactivated Covid vaccine (Vero cell) (0, 28 days).

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	saline
BIOLOGICAL	COVID-19 Vaccine (Vero Cell) ,Inactivated	COVILO
BIOLOGICAL	COVID-19 mRNA Vaccine (ZSVG-02-O) 10 μg	Low-dose
BIOLOGICAL	COVID-19 mRNA Vaccine (ZSVG-02-O) 30 μg	Mid-dose
BIOLOGICAL	COVID-19 mRNA Vaccine (ZSVG-02-O) 60 μg	High-dose

Timeline

• Start date: 2023-03-10
• Primary completion: 2023-06-30
• Completion: 2024-06-01
• First posted: 2023-11-02
• Last updated: 2023-11-08

Locations

1 site across 1 country: China