NCT05585567

A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
BIOLOGICAL	V-01/V-01-B5	Contains 10μg of V-01 and 10μg of V-01-B5
BIOLOGICAL	V-01-351/V-01-B5	Contains 10μg of V-01-351 and 10μg of V-01-B5
BIOLOGICAL	V-01	Contains 10μg of V-01

Timeline

• Start date: 2022-09-16
• Primary completion: 2022-10-14
• Completion: 2023-09-11
• First posted: 2022-10-19
• Last updated: 2022-11-07

Locations

1 site across 1 country: China