NCT04636697

Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults

Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30,918 (estimated)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	Intramuscular injection	Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
BIOLOGICAL	Intramuscular vaccine	Subjects will receive two doses of 3.75 µg of CoVLP adjuvanted with AS03 adjuvant given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)

Timeline

• Start date: 2020-11-19
• Primary completion: 2021-08-25
• Completion: 2022-04-30
• First posted: 2020-11-19
• Last updated: 2022-04-06

Locations

91 sites across 6 countries: United States, Argentina, Brazil, Canada, Mexico, United Kingdom

Regulatory

• FDA-regulated drug study