NCT05465902

Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster

Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: WestVac Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine.

Detailed description

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine. The study plans to enroll about 600 subjects aged 18 years and above (subjects aged ≥ 60 years account for approximately 10%) that would be divided into three cohorts according to different primary vaccination: Inactivated COVID-19 vaccines cohort, mRNA COVID-19 vaccines cohort and Viral Vector COVID-19 vaccines cohort, with approximately 200 cases in each cohort. The subjects will be randomized to the Recombinant COVID-19 variant Vaccine (Sf9 Cell) group (test group) or the inactivated COVID-19 vaccine (Vero cell) group or mRNA vaccine or Viral Vector vaccine (control group) in a ratio of 1:1.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 variant Vaccine (Sf9 Cell)	1dose, Intramuscular Injection
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	1dose, Intramuscular Injection
BIOLOGICAL	mRNA COVID-19 vaccine (Moderna)	1dose, Intramuscular Injection
BIOLOGICAL	Viral Vector COVID-19 vaccine (AstraZeneca)	1dose, Intramuscular Injection

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-11-30
• Completion: 2024-12-01
• First posted: 2022-07-20
• Last updated: 2025-03-28

Locations

1 site across 1 country: Mexico