SARS-CoV 2Phase 1NCT04450004
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
A Phase 1 study testing Intramuscular Vaccine in people with SARS-CoV 2, run by Medicago at 2 sites in Canada.
Trial summary
The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Intramuscular Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jul 2020to 30 Aug 2021
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits to be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be carefully and fully documented in the source documents:
- Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
- At the Screening visit (Visit 1), male and female subjects must be 18 to 55 (has not yet had his/her 56th birthday) years of age, inclusive;
- At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index (BMI) of ≥ 18.5 and < 25 kg/m2;
- Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
- Subjects must be healthy (no clinically significant health concerns) as determined by medical history, physical examination, vital signs, and clinical laboratory tests. Investigator discretion will be permitted with this inclusion criterion;
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- Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1) and a negative urine pregnancy test result at Vaccination (Visit 2 and Visit 4).
- Non-childbearing females are defined as:
- Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to the first study vaccination); or
- Post-menopausal (absence of menses for 12 consecutive months and age consistent with natural cessation of ovulation);
- Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last administration of the investigational product (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination). The following relationship or methods of contraception are considered to be highly effective:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral;
- Intravaginal;
- Transdermal;
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral;
- Injectable;
- Implantable;
- Intra-uterine device with or without hormonal release;
- Vasectomised partner, provided that this partner is the sole sexual partner of the study participant and that the vasectomised partner has received a medical assessment of the surgical success;
- Credible self-reported history of heterosexual vaginal intercourse abstinence prior to and for at least one month after the last administration of the investigational product ;
- Female partner.
Who cannot join
- Subjects who meet any of the following criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits will not be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be thoroughly documented in the source documents:
- Clinically significant acute or chronic pulmonary (including but not limited to chronic obstructive pulmonary disease or asthma), cardiovascular (including but not limited to arterial hypertension, coronary artery disease, or congestive heart failure), renal, metabolic (including but not limited to type 2 diabetes), or other somatic (medical) or neuropsychiatric illness within 3 months prior to Screening (Visit 1), excessive alcohol use or drug abuse, as determined by medical history, physical examination, vital signs, and clinical laboratory tests.
- Investigator discretion is permitted with this exclusion criterion and must be carefully and fully documented in the source documents;
- Any unexplained clinical syndrome (including, but not limited to, chronic fatigue syndrome, Raynaud's syndrome, unexplained pain syndromes such as fibromyalgia, etc.);
- Acute disease defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to Vaccination (Visit 2);
- Prior exposure to SARS-CoV-2 as determined by detection of IgM or IgG antibodies against SARS-CoV-2 at Screening (Visit 1) and Vaccination (Visit 2);
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- 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). Investigator discretion is permitted with this exclusion criterion;
- Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion, and subjects may be eligible to participate with appropriate written justification in the source document (i.e. subjects with a history of autoimmune disease who are disease-free without treatment for three years or more, or on stable thyroid replacement therapy, mild psoriasis [i.e. a small number of minor plaques requiring no systemic treatment], etc.);
- Administration of any medication or treatment that may alter the vaccine immune responses, such as:
- Systemic glucocorticoids within one month prior to Vaccination (Visit 2). Inhaled, nasal, dermal, intraarticular, ophthalmic 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 30 days prior to Vaccination (Visit 2); planned administration of any vaccine during the study (up to blood sampling on Day 42 of the study). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator;
- Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
- Known current or previous laboratory-confirmed SARS-CoV-1 or SARS-CoV-2 / COVID 19 infection as documented by a positive PCR test or positive serological test;
- Subjects at high risk of contracting SARS-CoV-2/COVID-19 infection, including but not limited to the individuals with known close contact of anyone with laboratory-confirmed SARS-CoV-2 / COVID-19 infection within 2 weeks prior to vaccine administration, those who traveled outside Canada for any duration within 30 days before the study vaccination, healthcare workers in acute care hospitals, rehabilitation hospitals, mental health hospitals, long term care facilities, emergency departments, and others who through their work must come into close face-to-face contact with their clients or patients (including, but not limited to, physiotherapists, dentists, hair dressers/barbers, etc.);
- 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. Investigator discretion will be permitted with this exclusion criterion;
- Use of any prescription medication on a regular basis for more than 30 continuous days within the last 3 months, with the following exceptions:
- Medications listed among the methods of contraception in inclusion criterion 7;
- Subjects on stable thyroid replacement therapy, as noted in exclusion criterion 6.
- 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);
- Use of prophylactic medications (e.g. antihistamines [H1 receptor antagonists], nonsteroidal anti-inflammatory drugs [NSAIDs], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination (Visit 2) to prevent or pre-empt symptoms due to vaccination;
- History of allergy to any of the constituents of the Coronavirus-Like Particle COVID-19 Vaccine, vaccine adjuvants, or tobacco;
- History of anaphylactic allergic reactions to plants or plant components (including fruits and nuts);
- Currently smoke more than 10 cigarettes per month or any use of vaping products;
- 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;
- Subjects identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study, or any employees of Medicago.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age
The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies.
At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
- Conditions
- SARS-CoV 2
- Being tested
- Intramuscular Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular VaccineBiological
Subjects will receive two intramuscular (IM) injections 21 days apart (Day 0 and Day 21), into the deltoid region of the alternating arm (each arm will be injected once), with their assigned vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine (3.75 µg) unadjuvanted | Experimental | • Group 1: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine Receives: Biological: Intramuscular Vaccine |
| Vaccine (3.75 µg) adjuvanted with CpG 1018 | Experimental | • Group 2: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 Receives: Biological: Intramuscular Vaccine |
| Vaccine (3.75 µg) adjuvanted with AS03 | Experimental | • Group 3: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 Receives: Biological: Intramuscular Vaccine |
| Vaccine (7.5 µg) unadjuvanted | Experimental | • Group 4: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine unadjuvanted Receives: Biological: Intramuscular Vaccine |
| Vaccine (7.5 µg) adjuvanted with CpG 1018 | Experimental | • Group 5: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 Receives: Biological: Intramuscular Vaccine |
| Vaccine (7.5 µg) adjuvanted with AS03 | Experimental | • Group 6: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 Receives: Biological: Intramuscular Vaccine |
| Vaccine (15 µg) unadjuvanted | Experimental | • Group 7: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine unadjuvanted Receives: Biological: Intramuscular Vaccine |
| Vaccine (15 µg) adjuvanted with CpG 1018 | Experimental | • Group 8: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 Receives: Biological: Intramuscular Vaccine |
| Vaccine (15 µg) adjuvanted with AS03 | Experimental | • Group 9: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 Receives: Biological: Intramuscular Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate adverse event (AEs)
Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs)
Measured: 30 minutes
Solicited local and systemic adverse events (AEs)
Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination
Measured: 7 days
Unsolicited adverse events (AEs)
Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration
Measured: 21 days
Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths
Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration
Measured: 21 days
Safety labs
Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.
Measured: 3 days
Neutralizing antibody (Nab assay) response
Nab response induced by the vaccine against the SARS-CoV-2 virus
Measured: 21 days
Specific Th1 cell-mediated immunity (CMI) response
Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot)
Measured: 21 days
Specific Th2 cell-mediated immunity (CMI) response
Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot
Measured: 21 days
Secondary outcomes (5)
Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths
Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths from 22 days after the last vaccination up to the end of the study
Measured: Day 42 to 386
Specific antibody response induced by the vaccine against the SARS-CoV-2 virus measured by total IgG and/or IgM levels
Specific antibody response induced by the vaccine against the SARS-CoV-2 virus, as measured by total IgG and/or IgM levels
Measured: Day 21, 42, 201 and 386
Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus
Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus
Measured: Day 201 and 386
Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IFN- γ ELISpot
Measured: Day 201 and 386
Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus measured by IL-4 ELISpot.
Measured: Days 201 and 386
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start10 Jul 2020
- Primary completion20 Sep 2020
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian J Ward, MD, Study director, Medicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450004
- Sponsor's protocol ID
- CP-PRO-COVLP-019
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ward BJ, Gobeil P, Seguin A, Atkins J, Boulay I, Charbonneau PY, Couture M, D'Aoust MA, Dhaliwall J, Finkle C, Hager K, Mahmood A, Makarkov A, Cheng MP, Pillet S, Schimke P, St-Martin S, Trepanier S, Landry N. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat Med. 2021 Jun;27(6):1071-1078. doi: 10.1038/s41591-021-01370-1. Epub 2021 May 18.
PubMed 34007070
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially-Blinded, Dose-Ranging Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID 19 Vaccine in Adults 18-55 Years of Age
- ClinicalTrials.gov ID
- NCT04450004
- Acronym / sponsor ID
- CP-PRO-COVLP-019
- Conditions
- SARS-CoV 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- MedicagoIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 29 Jun 2020 (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.
The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies.
At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Vaccine (3.75 µg) unadjuvanted | Experimental | Biological: Intramuscular Vaccine• Group 1: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine |
| Vaccine (3.75 µg) adjuvanted with CpG 1018 | Experimental | Biological: Intramuscular Vaccine• Group 2: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 |
| Vaccine (3.75 µg) adjuvanted with AS03 | Experimental | Biological: Intramuscular Vaccine• Group 3: 3.75 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 |
| Vaccine (7.5 µg) unadjuvanted | Experimental | Biological: Intramuscular Vaccine• Group 4: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine unadjuvanted |
| Vaccine (7.5 µg) adjuvanted with CpG 1018 | Experimental | Biological: Intramuscular Vaccine• Group 5: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 |
| Vaccine (7.5 µg) adjuvanted with AS03 | Experimental | Biological: Intramuscular Vaccine• Group 6: 7.5 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 |
| Vaccine (15 µg) unadjuvanted | Experimental | Biological: Intramuscular Vaccine• Group 7: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine unadjuvanted |
| Vaccine (15 µg) adjuvanted with CpG 1018 | Experimental | Biological: Intramuscular Vaccine• Group 8: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with CpG 1018 |
| Vaccine (15 µg) adjuvanted with AS03 | Experimental | Biological: Intramuscular Vaccine• Group 9: 15 µg of the Coronavirus-Like Particle COVID-19 Vaccine adjuvanted with AS03 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Subjects must meet all of the following inclusion criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits to be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be carefully and fully documented in the source documents:
- Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
- At the Screening visit (Visit 1), male and female subjects must be 18 to 55 (has not yet had his/her 56th birthday) years of age, inclusive;
- At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index (BMI) of ≥ 18.5 and < 25 kg/m2;
- Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
Key exclusion criteria (29 listed)
- Subjects who meet any of the following criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits will not be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be thoroughly documented in the source documents:
- Clinically significant acute or chronic pulmonary (including but not limited to chronic obstructive pulmonary disease or asthma), cardiovascular (including but not limited to arterial hypertension, coronary artery disease, or congestive heart failure), renal, metabolic (including but not limited to type 2 diabetes), or other somatic (medical) or neuropsychiatric illness within 3 months prior to Screening (Visit 1), excessive alcohol use or drug abuse, as determined by medical history, physical examination, vital signs, and clinical laboratory tests.
- Investigator discretion is permitted with this exclusion criterion and must be carefully and fully documented in the source documents;
- Any unexplained clinical syndrome (including, but not limited to, chronic fatigue syndrome, Raynaud's syndrome, unexplained pain syndromes such as fibromyalgia, etc.);
- Acute disease defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to Vaccination (Visit 2);
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 |
|---|---|---|
| Intramuscular VaccineSubjects will receive two intramuscular (IM) injections 21 days apart (Day 0 and Day 21), into the deltoid region of the alternating arm (each arm will be injected once), with their assigned vaccine. | Biological | Vaccine (15 µg) adjuvanted with AS03, Vaccine (15 µg) adjuvanted with CpG 1018, Vaccine (15 µg) unadjuvanted, Vaccine (3.75 µg) adjuvanted with AS03, Vaccine (3.75 µg) adjuvanted with CpG 1018, Vaccine (3.75 µg) unadjuvanted, Vaccine (7.5 µg) adjuvanted with AS03, Vaccine (7.5 µg) adjuvanted with CpG 1018, Vaccine (7.5 µg) unadjuvanted |
Primary outcome
Immediate adverse event (AEs)
Time frame: 30 minutes
Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs)
Solicited local and systemic adverse events (AEs)
Time frame: 7 days
Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination
Unsolicited adverse events (AEs)
Time frame: 21 days
Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration
Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths
Time frame: 21 days
Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration
Safety labs
Time frame: 3 days
Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.
Neutralizing antibody (Nab assay) response
Time frame: 21 days
Nab response induced by the vaccine against the SARS-CoV-2 virus
Specific Th1 cell-mediated immunity (CMI) response
Time frame: 21 days
Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot)
Specific Th2 cell-mediated immunity (CMI) response
Time frame: 21 days
Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot
5 secondary outcomes
Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths
Time frame: Day 42 to 386
Specific antibody response induced by the vaccine against the SARS-CoV-2 virus measured by total IgG and/or IgM levels
Time frame: Day 21, 42, 201 and 386
Neutralizing antibody (Nab assay) response induced by the treatment groups against the SARS-CoV-2 virus
Time frame: Day 201 and 386
Specific Th1 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
Time frame: Day 201 and 386
Specific Th2 cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
Time frame: Days 201 and 386
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 34007070Ward BJ, Gobeil P, Seguin A, Atkins J, Boulay I, Charbonneau PY, Couture M, D'Aoust MA, Dhaliwall J, Finkle C, Hager K, Mahmood A, Makarkov A, Cheng MP, Pillet S, Schimke P, St-Martin S, Trepanier S, Landry N. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat Med. 2021 Jun;27(6):1071-1078. doi: 10.1038/s41591-021-01370-1. Epub 2021 May 18.
- Individual participant dataSharing planned: No
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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.
Brian J Ward, MD study director
Medicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intramuscular Vaccine in people with SARS-CoV 2, 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 23 inclusion and 29 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: finished, as of the sponsor's last update on 6 Apr 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immediate adverse event (AEs) (time frame: 30 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04450004, which also lists 1 linked publication.
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 6 Apr 2022.