| Eligibility |
Inclusion Criteria:
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:
1. 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;
2. 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;
3. At Screening (Visit 1) and Vaccination (Visit 2), subject must have a body mass index
(BMI) of = 18.5 and < 25 kg/m2;
4. 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;
5. 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;
6. 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 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.
Exclusion Criteria:
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:
1. 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;
2. Any unexplained clinical syndrome (including, but not limited to, chronic fatigue
syndrome, Raynaud's syndrome, unexplained pain syndromes such as fibromyalgia, etc.);
3. 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);
4. 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);
5. 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;
6. 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.);
7. 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:
- 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 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);
16. 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;
17. History of allergy to any of the constituents of the Coronavirus-Like Particle
COVID-19 Vaccine, vaccine adjuvants, or tobacco;
18. History of anaphylactic allergic reactions to plants or plant components (including
fruits and nuts);
19. Currently smoke more than 10 cigarettes per month or any use of vaping products;
20. Subjects with a history of Guillain-Barré Syndrome;
21. Any female subject who has a positive or doubtful pregnancy test result prior to
vaccination or who is lactating;
22. 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.
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