NCT05040789

Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine

A Randomized, Observer-Blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18-49 Years of Age

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 study is intended to assess clinical lot-to-lot consistency by evaluating and comparing the immunogenicity of three consecutively manufactured lots of Coronavirus-like Particle (CoVLP).

Detailed description

This is a randomized, observer-blinded, multicenter, Phase 3 lot-to-lot consistency study in approximately 900 healthy seronegative adults 18-49 years of age after the administration of two doses of CoVLP (3.75 ug) adjuvanted with AS03 (referred to as "CoVLP formulation"). Subjects who are seronegative for SARS-CoV-2 antibodies will be randomized in a 1:1:1 ratio to receive one of three lots of the CoVLP formulation. Subjects will receive two intramuscular injections 21 days apart. The same lot will be used for both IM injections in each subject. Safety and immunogenicity assessments will be performed. Subjects will participate in this study for approximately 49 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	CoVLP formulation	The Coronavirus-Like Particle (CoVLP) COVID-19 Vaccine is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs). The 3.75 µg dose of CoVLP will be administered with the adjuvant AS03 (manufactured by GlaxoSmithKline).

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-09-10
• Last updated: 2023-06-02

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study