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
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); 7\. 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 throughout participation in the trial (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 until the end of the study (up to Day 201)
Female partner
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
Yes for 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 exclusion criteria 5
No for 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 exclusion criteria 5
Not sure for 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 exclusion criteria 5
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
)
\. 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); 8\. 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; 9\. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study; 10\. 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; 11\. 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.); 12\. 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; 13\. 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; 14\. Use of any prescription medication on a regular basis for more than 30 continuous days within the last 3 months, with the following exceptions
Yes for Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2); 8\. 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; 9\. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study; 10\. 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; 11\. 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.); 12\. 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; 13\. 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; 14\. Use of any prescription medication on a regular basis for more than 30 continuous days within the last 3 months, with the following exceptions exclusion criteria 33
No for Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2); 8\. 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; 9\. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study; 10\. 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; 11\. 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.); 12\. 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; 13\. 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; 14\. Use of any prescription medication on a regular basis for more than 30 continuous days within the last 3 months, with the following exceptions exclusion criteria 33
Not sure for Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to Vaccination (Visit 2); 8\. 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; 9\. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study; 10\. 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; 11\. 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.); 12\. 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; 13\. 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; 14\. Use of any prescription medication on a regular basis for more than 30 continuous days within the last 3 months, with the following exceptions exclusion criteria 33
Medications listed among the methods of contraception in inclusion criterion 7
Subjects on stable thyroid replacement therapy, as noted in exclusion criterion 6\. 15\. 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; 16\. History of allergy to any of the constituents of the Coronavirus-Like Particle COVID-19 Vaccine, vaccine adjuvants, or tobacco; 17\. History of anaphylactic allergic reactions to plants or plant components (including fruits and nuts); 18\. Currently smoke more than 10 cigarettes per month or any use of vaping products; 19\. Subjects with a history of Guillain-Barr Syndrome; 20\. Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating; 21\. 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
Yes for Subjects on stable thyroid replacement therapy, as noted in exclusion criterion 6\. 15\. 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; 16\. History of allergy to any of the constituents of the Coronavirus-Like Particle COVID-19 Vaccine, vaccine adjuvants, or tobacco; 17\. History of anaphylactic allergic reactions to plants or plant components (including fruits and nuts); 18\. Currently smoke more than 10 cigarettes per month or any use of vaping products; 19\. Subjects with a history of Guillain-Barr Syndrome; 20\. Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating; 21\. 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 exclusion criteria 35
No for Subjects on stable thyroid replacement therapy, as noted in exclusion criterion 6\. 15\. 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; 16\. History of allergy to any of the constituents of the Coronavirus-Like Particle COVID-19 Vaccine, vaccine adjuvants, or tobacco; 17\. History of anaphylactic allergic reactions to plants or plant components (including fruits and nuts); 18\. Currently smoke more than 10 cigarettes per month or any use of vaping products; 19\. Subjects with a history of Guillain-Barr Syndrome; 20\. Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating; 21\. 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 exclusion criteria 35
Not sure for Subjects on stable thyroid replacement therapy, as noted in exclusion criterion 6\. 15\. 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; 16\. History of allergy to any of the constituents of the Coronavirus-Like Particle COVID-19 Vaccine, vaccine adjuvants, or tobacco; 17\. History of anaphylactic allergic reactions to plants or plant components (including fruits and nuts); 18\. Currently smoke more than 10 cigarettes per month or any use of vaping products; 19\. Subjects with a history of Guillain-Barr Syndrome; 20\. Any female subject who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating; 21\. 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 exclusion criteria 35