NCT04636697

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

Active, enrolled Phase 2, PHASE3 Last updated 6 April 2022

What this trial tests

Phase 2, PHASE3 trial testing Intramuscular injection in SARS-CoV-2 Infection in 30,918 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 November 2020

Primary endpoint
25 August 2021

30 April 2022

Quick facts

Lead sponsor	Medicago
Phase	Phase 2, PHASE3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	30,918
Start date	19 November 2020
Primary completion	25 August 2021
Estimated completion	30 April 2022
Sites	91 locations across United Kingdom, Mexico, Argentina, Canada, United States, Brazil

Drugs / interventions tested

• Intramuscular injection — full drug profile →
• Intramuscular vaccine — full drug profile →

Conditions studied

• SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →

Sponsor

Medicago — full company profile →

Who can join

18 and older, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
   Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
2. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
   Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
3. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
4. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
   Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
5. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
6. Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine.
   Hager KJ, Pérez Marc G, Gobeil P, Diaz RS, et al · · 2022 · cited 172× · PMID 35507508 · DOI 10.1056/nejmoa2201300
7. Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies.
   Cid R, Bolívar J. · · 2021 · cited 98× · PMID 34439738 · DOI 10.3390/biom11081072
8. SARS-CoV-2 (Covid-19) vaccines structure, mechanisms and effectiveness: A review.
   Fathizadeh H, Afshar S, Masoudi MR, Gholizadeh P, et al · · 2021 · cited 97× · PMID 34403674 · DOI 10.1016/j.ijbiomac.2021.08.076