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Virus Therapy

Intramuscular vaccine for COVID-19

Phase 2 & 3
Waitlist Available
Research Sponsored by Medicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through efficacy analysis, approximately 4 months

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.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through efficacy analysis, approximately 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through efficacy analysis, approximately 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 2 portion: Immediate adverse event (AEs)
Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values
Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values
+9 more
Secondary study objectives
Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Phase 2 portion: Neutralizing antibody (Nab assay) response
Antibodies, Blocking
+27 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 3.75 µg of CoVLP Vaccine adjuvantedExperimental Treatment1 Intervention
3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
Group II: PlaceboPlacebo Group1 Intervention
Placebo (0.5 mL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intramuscular vaccine
2011
Completed Phase 4
~420

Find a Location

Who is running the clinical trial?

MedicagoLead Sponsor
18 Previous Clinical Trials
28,442 Total Patients Enrolled
3 Trials studying COVID-19
308 Patients Enrolled for COVID-19
Brian Ward, MDStudy DirectorMedicago
5 Previous Clinical Trials
1,597 Total Patients Enrolled
~6184 spots leftby Nov 2025
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