NCT05096845

Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22,500 (estimated)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

Detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III clinical study. Approximately 22,500 participants aged 18 years and older will be enrolled in this study to evaluate the efficacy, safety and immunogenicity of recombinant SARS-CoV-2 fusion protein vaccine (code: V-01, hereinafter referred to as V-01). The eligible participants will be randomized in a 2:1 ratio into investigational vaccine group (V-01) and placebo group, with random stratification factors including 1) age (18-59 years vs ≥60 years); 2) gender (male vs female); and 3) whether or not being enrolled into immunogenicity subgroup (yes vs no). The participants will receive investigational vaccine V-01 or placebo on two doses schedule (one dose each on day 0 and 21, with +7 days' time window for the second dose).

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant SARS-CoV-2 fusion protein vaccine (V-01)	Appearance: creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively. Storage condition: store at 2\~8°C protected from light Expiry date: 24 months after production date
OTHER	Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)	The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.

Timeline

• Start date: 2021-08-25
• Primary completion: 2022-02-08
• Completion: 2023-06-14
• First posted: 2021-10-27
• Last updated: 2023-04-25

Locations

25 sites across 3 countries: Indonesia, Philippines, Russia