NCT05323435

Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV)

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Phase II Study to Evaluate the Immunogenicity and Safety of One Dose Booster by Recombinant Two-Component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Jiangsu Rec-Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, observer-blinded, active-controlled Phase II study to evaluate the immunogenicity, safety and reactogenicity of the low dose (20μg) and high dose (40μg) of ReCOV, when administered as a booster to healthy adults aged 18 to 65 years who have completed two or three doses vaccination (prioritized two doses). Estimate 300 participants.

Detailed description

The study is a multicenter, randomized, observer-blinded, active-controlled trial. About 300 eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV group, and the control vaccine \[COVID-19 Vaccine (Vero Cell), Inactivated\] group, respectively, stratified by age (18 to \< 50 years, ≥ 50 to ≤ 65 years) and the duration since the last dose of primary vaccination (90\~180 days, 181\~365 days). All Participants will be observed for 30 minutes after study vaccination at study site if Participants will be asked to record solicited AEs within 7 days and unsolicited AEs within28 days. After 28 days post the study vaccination，all participants will have 2 on-site safety follow-up Visits on Day 90 (±15days) and on Day 180 (±15days) after the study vaccination to collect serious adverse evens (SAEs), adverse events of special interest (AESIs). During the study period, they can spontaneously report any adverse events (AEs) they experienced at any time.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant two-component COVID-19 vaccine (CHO cell)	Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	Milky-white suspension.Stratified precipitate may form which can be dispersed by shaking

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-07-05
• Completion: 2023-01-16
• First posted: 2022-04-12
• Last updated: 2023-04-25

Locations

1 site across 1 country: United Arab Emirates