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Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before the first study-specific procedure |
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Healthy volunteers aged above 18 years at time of screening |
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Have received last COVID-19 vaccination more than 3 months ago (more than 90 days) [Only Step 1] |
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Participants must have a body mass index (BMI) between ≥18.5 and ≤30.0 kg/m2 at screening |
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Availability to volunteer for the entire study duration and be willing to adhere to all protocol requirements |
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Must have a negative urine pregnancy test on the day of dosing prior to each vaccination |
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Must agree not to donate blood or receive transfusion (including whole blood, plasma, and platelet components) |
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Must agree to use highly effective, medically accepted double-barrier contraception (both male and female partners) from screening until study completion (until 3 months after second vaccination) as specified below in this criterion |
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Highly effective double-barrier contraception is defined as use of a condom AND one of the |
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following |
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Birth control pills (The Pill) |
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Depot or injectable birth control |
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IUD (Intrauterine Device) |
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Birth Control Patch (e.g., Ortho Evra) |
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NuvaRing® |
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Implantable contraception (e.g., Implanon) |
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Documented evidence of surgical sterilisation at least 6 months prior to screening |
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i.e., tubal ligation for female or vasectomy for male Rhythm methods are not |
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considered as highly effective methods of birth control. Female participants and |
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female partners of male participants must use contraception from the time of informed |
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consent and for 90 days after last vaccination of study drug |
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Female not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal |
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status will be confirmed through testing of follicle stimulating hormone (FSH) levels ≥ 40 |
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IU/mL at screening for amenorrhoeic female participants |
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Male participants must refrain from sperm donation from start of study and for 90 days |
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after the last vaccination of study drug |
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Female participants who has had hysterectomy at least 6 months prior to screening must |
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provide documented evidence of surgical sterilisation and are not required to use double |
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barrier contraception where this is the usual and preferred lifestyle |
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Participants who are in same-sex relationships are not required to use contraception |
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Abstinence is acceptable where this is the usual and preferred lifestyle |
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Participant with the evidence of COVID-19 infection because of one or more of the
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following
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Positive for COVID-19 when performing RT-PCR with upper respiratory tract
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samples; (oropharyngeal/nasopharyngeal swab), (However, if symptoms of cough or
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sputum are present, additional RT-PCR is performed using a lower respiratory
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tract sample (sputum), and registration is possible if all are negative)
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History of COVID-19
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Close contact with a person infected with COVID-19 or have been classified as
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symptomatic person to COVID-19 within 14 days prior to the first vaccination
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Symptomatic person
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According to the doctor's opinion, COVID-19 is suspected as a clinical symptom
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History of travel outside of the country and have clinical symptoms of COVID-19
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within 14 days of return
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Healthcare workers who can participate in the treatment of COVID-19 patients, or those
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at high risk of exposure to SARS-CoV-2 (screening clinics and emergency room workers
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workers related to COVID-19 prevention, workers involved in collecting or analysing
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COVID-19 samples, etc.)
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Clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or
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chest X-rays performed at the screening
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Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HbsAg)
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human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
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Is acutely febrile or ill 72 hours prior to the first vaccination
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Fever is defined as a body temperature ≥38.0°Celsius / ≥100.4°Farenheit
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Illness is defined as symptoms due to other infectious diseases (Cough, shortness
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of breath, chills, muscle pain, headache, sore throat, loss of smell, or loss of
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taste, etc.)
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History of a diagnosis or condition that, in the judgment of the Investigator, may
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affect study endpoint assessment or participant safety, specifically
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Respiratory system: asthma, chronic obstructive pulmonary disease (COPD), daily
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medication administration for active tuberculosis or latent tuberculosis
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received treatment due to worsening of respiratory diseases within 5 years prior
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to the first vaccination
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Serious cardiovascular disease: Congestive heart failure, coronary artery
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disease, myocardial infarction, uncontrolled hypertension, myocarditis
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pericarditis, etc
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Nervous system: Epilepsy, seizure (Within 3 years before the first vaccination)
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migraine, stroke, encephalopathy, Guillain-Barré syndrome, encephalomyelitis
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transverse myelitis, etc
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Diagnosis of malignancy within the previous 10 years before the first vaccination
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(except basal cell and squamous cell carcinoma)
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Autoimmune diseases, including autoimmune hypothyroidism or psoriasis
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Immunodeficiency disease
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Hepatobiliary, renal, endocrine, urinary, musculoskeletal or other disorders
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judged to be clinically significant by the investigator
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History of SARS-CoV or MERS-CoV infection
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History of allergy or hypersensitivity reaction to any components of study vaccine
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History of serious adverse reaction, allergy or hypersensitivity reaction to any
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vaccination
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History of platelet-related disease or hemorrhagic disease, or have a history of
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severe bleeding or bruising after intramuscular injection (IM) or venipuncture, or are
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taking anticoagulants; (However, according to the judgment of the investigators, there
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can be involved when using a low dose of an anticoagulant (eg, aspirin at 100mg/day or
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less))
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History of urticarial within 5 years before the first vaccination
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History of hereditary or idiopathic angioneurotic edema
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History of organ or bone marrow transplantation
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History or suspicion of illegal substance use or alcohol abuse within the past 6
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months before the first vaccination
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(Step II only) Previous vaccination history of mRNA based COVID-19 vaccine
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Prior administration of an investigational substance vaccine
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Receipt of chronic use of the following drugs within 6 months before the first
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vaccination
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Immunosuppressants and immunomodulators: Azathioprine, cyclosporine, interferon
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G-CSF, tacrolimus, everolimus, sirolimus, cyclophosphamide, 6-mercaptopurine
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methotrexate, rapamycin, leflunomide, etc
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Systemic steroids: When a dose exceeding 10 mg/day and has been used for more
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than 14 consecutive days based on prednisolone (However, external steroids, nasal
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sprays, inhalants, and eye drops are permitted regardless of the dosage)
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History of dependent psychotropic or opioid drug within 6 months before the first
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vaccination
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Participated in an interventional clinical study within 6 months prior to the
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screening visit or plans to do so while participating in this study
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Participants have been vaccinated or plan to vaccinate within 4 weeks before/after
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each vaccination
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Participants have received immunoglobulin or blood-derived products within 3 months
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prior to the first vaccination, or those who plan to administer it during the study
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Participants scheduled for surgery while participating in this study
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Pregnant or lactating at screening or planning to become pregnant (Self or partner) at
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any time during the study, including the follow-up period
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Any other reason that, in the opinion of the investigator, unlikely to comply with the
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clinical study protocol or is unsuitable for any other reason
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Any kinds of COVID-19 vaccination history are allowed for Step I, but each
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COVID-19 vaccination history is allowed for Step II except mRNA based COVID-19
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vaccine. IP should be vaccinated to subject minimal 3 months after last
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vaccination of previous COVID-19 vaccine
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