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

NCT05040789 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CP-PRO-CoVLP-024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Day 42 (21 days after the second vaccination)

Secondary Outcomes (6)

• Immediate adverse events

  30 minutes after each vaccine administration

• Solicited adverse events

  Seven days following each vaccination

• Unsolicited adverse events

  21 days following each vaccination

• Other adverse events

  Up to 21 days following each vaccine administration

• SC rates

  21 days after the second vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

CoVLP Lot 1

Biological: CoVLP formulation

Group 2

EXPERIMENTAL

CoVLP Lot 2

Biological: CoVLP formulation

Group 3

EXPERIMENTAL

CoVLP Lot 3

Biological: CoVLP formulation

Interventions

CoVLP formulation BIOLOGICAL

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).

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects must be 18 - 49 years of age at screening visit.
• Subjects must have a body mass index \< 35 kg/m2 at screening visit.
• Subjects must be in good general health prior to study participation. Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and the condition is unlikely to confound the results of the study or pose additional risk to the subject.
• Female subjects of childbearing potential must have a negative urine pregnancy test result prior to vaccination.
• Female subjects of childbearing potential must use a highly effective method of contraception starting one month prior to vaccination, continuing until the end of the study, and must not plan to become pregnant for at least one month after her last study vaccination.

You may not qualify if:

• Significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
• Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus (HIV), hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed).
• Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis).
• Administration of any medication or treatment that may alter the vaccine immune responses, such as:
• Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the Vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted.
• Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to Vaccination (Visit 2).
• Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2).
• Administration of any vaccine within 14 days prior to Vaccination (Visit 2); planned administration of any vaccine during the study (up to Day 28 of the study).
• Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study.
• History of virologically-confirmed COVID-19.
• Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to Vaccination (Visit 2) or planned use during the study period.
• Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating.
• Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that are thought to be effective for prevention of COVID-19 but have not been licensed for this indication, within one month prior to Vaccination (Visit 2).
• History of a serious allergic response to any of the constituents of CoVLP including AS03.
• History of a documented anaphylactic reactions to plants or plant components (including tobacco, fruits and nuts).

Sponsors & Collaborators

• Medicago: lead

Study Sites (2)

Dawson Clinical Research

Guelph, Ontario, N1H 1B1, Canada

Location

LMC Manna Research

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 10, 2021
• Study Start: November 22, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CA (2)