NCT05050474

Booster Immunization Study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

A Clinical Study to Evaluate the Immunogenicity and Safety of the Third Dose Booster Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01. The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01. The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

Detailed description

The plan is to booster immunize the participants previously in 10μg test group in V-01 clinical trial phase I, 48 participants are planned to be enrolled. The actual case number will be calculated by the participants who signed the ICF and got actual inoculation with the third dose. Vaccination and follow-up: Three to six months after the two doses of V-01 (10 μg) were vaccinated, the participants received a booster dose of investigational vaccine (V-01, 10 μg) at the deltoid muscle of the upper arm. Perform safety and immunogenicity related inspections in accordance with the schedule in the plan.

Conditions

• COVID19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant SARS-CoV-2 Fusion Protein Vaccine	The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.

Timeline

• Start date: 2021-08-07
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2021-09-20
• Last updated: 2023-04-25

Locations

1 site across 1 country: China