NCT05465785

A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell)

A Clinical Trial to Evaluate the Immunogenicity Bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in Healthy Population Aged 18-59 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: WestVac Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with immunization procedures 0, 21, 42 days .

Detailed description

This is a randomized, double-blind , non-inferiority design study, to evaluate the Immunogenicity bridging between different manufacture scales of Recombinant COVID-19 Vaccine (Sf9 Cell) in healthy population aged 18-59 years with vaccination course 0, 21, 42 days. 892 subjects aged 18-59 years are recruited and randomly inoculated in a 1:1 ratio from a pilot or commercial batch of Recombinant COVID-19 Vaccine (Sf9 Cell).

Conditions

• COVID-19
• SARS-CoV-2 Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 vaccine (Sf9 cell)	This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-03-11
• Completion: 2023-12-30
• First posted: 2022-07-20
• Last updated: 2024-04-24

Locations

1 site across 1 country: China