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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
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).
Dawson Clinical Research
Guelph, Ontario, Canada
LMC Manna Research
Toronto, Ontario, Canada
GMTs of the three vaccine lots
Nab response induced against the SARS-CoV-2 virus on Day 42 will be analyzed using GMTs of the three vaccine lots on Day 42 adjusted for Day 0 GMTs.
Time frame: Up to Day 42 (21 days after the second vaccination)
Immediate adverse events
Occurrence, intensity, and relationship to vaccination of immediate adverse events.
Time frame: 30 minutes after each vaccine administration
Solicited adverse events
Occurrence and intensity of solicited local and systemic adverse events.
Time frame: Seven days following each vaccination
Unsolicited adverse events
Occurrence, intensity, and relationship of unsolicited adverse events.
Time frame: 21 days following each vaccination
Other adverse events
Occurrences of serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal, AE of special interest (AESIs; including vaccine-associated enhanced disease \[VAED\], anaphylaxis, and severe allergic reactions), and deaths.
Time frame: Up to 21 days following each vaccine administration
SC rates
Nab response induced by CoVLP (3.75 µg/dose) adjuvanted with AS03 against the SARS-CoV-2 virus on Day 0 and Day 42 will be analyzed using SC rates
Time frame: 21 days after the second vaccination
GMFRs
Nab response induced by CoVLP (3.75 µg/dose) adjuvanted with AS03 against the SARS-CoV-2 virus on Day 0 and Day 42 will be analyzed using GMFRs
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Time frame: 21 days after the second vaccination