NCT05239832

Recombinant SARS-CoV-2 Fusion Protein Vaccine Booster Immunization Study to Evaluate the Safety and Immunogencity

A Clinical Study to Evaluate the Safety and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Clinical Study to Evaluate the Safety and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines

Detailed description

This is a single arm, open-label clinical study. 34 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines will be enrolled in this study to evaluate the safety and immunogenicity of V-01. The participants will be collected blood before immunization, on day 7, day 14, day 28, day 90 and 6 month to evaluate humoral immunity. All adverse events (AEs) within 30 minutes and 0-7 days after booster immunization, and unsolicited AEs from 8 to 28 days after booster immunization, as well as SAEs and AESIs from the first vaccination to 12 months after booster immunization will be collected from all participants.

Conditions

• COVID-19 Pandemic

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: 2021-08-05
• Primary completion: 2021-09-29
• Completion: 2022-08-05
• First posted: 2022-02-15
• Last updated: 2022-03-03

Locations

1 site across 1 country: China