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

NCT04636697 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30918

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Brian Ward, MD · Medicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2021-08-25
Completion
2022-04-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636697 on ClinicalTrials.gov