COVID-19Phase 3NCT05040789
Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine
A Phase 3 study testing CoVLP formulation in people with COVID-19, run by Medicago at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CoVLP formulation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Nov 2021to 31 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
- Personal or family (first-degree relatives) history of narcolepsy.
- Subjects with a history of Guillain-Barré Syndrome.
- Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dawson Clinical Research
Guelph, Ontario, N1H 1B1
LMC Manna Research
Toronto, Ontario, M4G 3E8
About this study
Official title: A Randomized, Observer-Blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18-49 Years of Age
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).
Read the detailed description
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.
- Conditions
- COVID-19
- Being tested
- CoVLP formulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoVLP formulationBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | CoVLP Lot 1 Receives: Biological: CoVLP formulation |
| Group 2 | Experimental | CoVLP Lot 2 Receives: Biological: CoVLP formulation |
| Group 3 | Experimental | CoVLP Lot 3 Receives: Biological: CoVLP formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 42 (21 days after the second vaccination)
Secondary outcomes (6)
Immediate adverse events
Occurrence, intensity, and relationship to vaccination of immediate adverse events.
Measured: 30 minutes after each vaccine administration
Solicited adverse events
Occurrence and intensity of solicited local and systemic adverse events.
Measured: Seven days following each vaccination
Unsolicited adverse events
Occurrence, intensity, and relationship of unsolicited adverse events.
Measured: 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.
Measured: 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
Measured: 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
Measured: 21 days after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start22 Nov 2021 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: Further development terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040789
- Sponsor's protocol ID
- CP-PRO-CoVLP-024
- Status last verified
- May 2023
- First submitted
- 26 Aug 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18-49 Years of Age
- ClinicalTrials.gov ID
- NCT05040789
- Acronym / sponsor ID
- CP-PRO-CoVLP-024
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Further development terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedicagoIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2021 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: CoVLP formulationCoVLP Lot 1 |
| Group 2 | Experimental | Biological: CoVLP formulationCoVLP Lot 2 |
| Group 3 | Experimental | Biological: CoVLP formulationCoVLP Lot 3 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoVLP formulationThe 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). | Biological | Group 1, Group 2, Group 3 |
Primary outcome
GMTs of the three vaccine lots
Time frame: Up to Day 42 (21 days after the second vaccination)
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.
6 secondary outcomes
Immediate adverse events
Time frame: 30 minutes after each vaccine administration
Solicited adverse events
Time frame: Seven days following each vaccination
Unsolicited adverse events
Time frame: 21 days following each vaccination
Other adverse events
Time frame: Up to 21 days following each vaccine administration
SC rates
Time frame: 21 days after the second vaccination
GMFRs
Time frame: 21 days after the second vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CoVLP formulation in people with COVID-19, run by Medicago at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMTs of the three vaccine lots (time frame: Up to Day 42 (21 days after the second vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.