NCT06381843

A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster

A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster in People Aged 18-60 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: WestVac Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation. A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 Vaccine (Sf9 Cell)	1dose, Intramuscular Injection
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	1dose, Intramuscular Injection

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-03-29
• Completion: 2023-12-30
• First posted: 2024-04-24
• Last updated: 2024-04-25

Locations

1 site across 1 country: China