NCT05716347

Clinical Trial of Safety and Immunogenicity of Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cells) as Booster Vaccination in Populations Aged 18 to 59 Years

Safety and Immunogenicity of a Recombinant SARS-CoV-2 S-Trimer Vaccine (CHO Cell) as Booster Shots in Healthy Adults Aged 18-59 Years Who Have Completed Two Doses of Inactivated SARS-CoV-2 Vaccine

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Binhui Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

Increased immune escape of emerging SARS-CoV-2 variants and waning neutralizing antibody levels over time indicate the importance of COVID-19 vaccine booster dose. Preclinical findings have shown that the recombinant SARS-CoV-2 S-Trimer vaccine exhibited favorable safety and immunogenicity. Herein, we conducted a randomized, open-label, positive control trial to assess the safety and immunogenicity of the booster shot in healthy subjects aged 18-59 years who have completed two-dose primary series of inactivated vaccine for 6-15 months. A total of 63 eligible participants were enrolled to receive the recombinant SARS-CoV-2 S-Trimer vaccine or inactivated vaccine, and only one participant in 30 μg recombinant SARS-CoV-2 S-Trimer vaccine cohort withdrew owing to personal work reasons on September 26, 2022. Subjects in each dose group (5 μg, 10 μg, 30 μg recombinant SARS-CoV-2 S-Trimer vaccine) was randomly assigned to receive the experimental vaccine or inactivated vaccine in a 2:1 ratio.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	the recombinant SARS-CoV-2 S-Trimer vaccine/inactivated SARS-CoV-2 vaccine	one booster dose intramuscularly in the deltoid muscle of the upper arm.

Timeline

• Start date: 2022-07-13
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2023-02-08
• Last updated: 2025-07-28

Locations

1 site across 1 country: China