| Eligibility |
Inclusion Criteria:
1. Healthy adult men and women between the ages of 50 and 69 years old
2. Have a body mass index (BMI) of at least 18 kg/m2 and no more than 30 kg/m2 at the
screening visit
3. Men and women who agree to use a highly effective method of contraception (*See
section 8.7 of the protocol) (however, not women of childbearing age or men who do not
have a spouse (partner) may be enrolled regardless of method of contraception).
- Women of childbearing potential: Practiced a highly effective method of birth
control for 4 weeks prior to the first dose of study medication and agreed to
continue to use a highly effective method of birth control for the duration of
the study (up to 3 months after the last dose of study medication).
- Men who have a spouse (partner): Has agreed to use a highly effective method of
birth control for the duration of the study (up to 3 months after the last dose
of study medication).
4. Agree to refrain from donating blood and transfusions (whole blood, plasma components,
platelet components, platelet-plasma components) for the duration of the study.
5. After receiving and understanding a detailed explanation of this clinical trial,
voluntarily decide to participate and give written consent.
6. For women of childbearing potential, a negative pregnancy test prior to receiving the
investigational drug.
Exclusion Criteria:
1. Clinically significant abnormalities on clinical laboratory tests, electrocardiogram
(ECG), or chest x-ray at screening.
2. Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test results
at screening.
3. Active pulmonary infection within 14 days prior to the first dose of investigational
medicinal product, or any other significant infectious disease that, in the opinion of
the investigator, would render the subject ineligible for participation in the study.
4. Have had an acute febrile illness of 38 degrees or greater within 3 days prior to the
first dose of investigational drug
5. Have any of the following conditions, or any serious medical or neuropsychiatric
condition that, in the opinion of the investigator, would make them ineligible to
participate in this study.
- Respiratory disease: asthma, chronic obstructive pulmonary disease (COPD), active
tuberculosis, or latent tuberculosis.
- Serious cardiovascular disease: Congestive heart failure, coronary artery
disease, myocardial infarction, uncontrolled hypertension, myocarditis,
pericarditis, etc.
- Nervous system disease: epilepsy, seizures (within 3 years prior to
first dose of investigational drug), migraine, stroke, cerebral
lesions, Guillain-Barré syndrome, encephalomyelitis, transverse
myelitis, dementia, etc.
? History of malignancy within 5 years prior to the first dose of
investigational drug and a history of malignant disease with a high
risk of recurrence (skin basal cell carcinoma and squamous cell
carcinoma with a minimal risk of recurrence based on clinical judgment
may be eligible).
? Autoimmune diseases including autoimmune hypothyroidism and psoriasis
? Immunodeficiency diseases
? Thrombosis at uncommon sites, such as cerebral venous sinus
thrombosis and visceral venous thrombosis, and heparin-induced
thrombocytopenia or antiphospholipid syndrome
? Capillary leak syndrome
? Other hepatobiliary, renal, endocrine, urinary, or musculoskeletal
diseases deemed clinically significant by the investigator
6. History of allergic reactions or hypersensitivity to any of the components of the
investigational drug.
7. History of serious adverse events, serious allergic reactions, or serious
hypersensitivity reactions related to vaccination.
8. History of platelet-related or hemorrhagic disease (such as major venous and/or
arterial thrombosis with thrombocytopenia), or history of excessive bleeding or
bruising after intramuscular injection or venipuncture, or receiving anticoagulant
therapy (except that patients may participate if they are using low-dose
anticoagulants (e.g., aspirin <100 mg/day) as determined by the investigator).
9. History of systemic urticaria within 5 years prior to the first dose of
investigational drug.
10. Have a history of hereditary or idiopathic angioneurotic edema
11. History of organ or bone marrow transplantation
12. History of dependent use of antipsychotics or narcotic analgesics within 6 months
prior to the first dose of study medication, or psychiatric or social conditions that,
in the opinion of the investigator, would make it difficult to comply with the
procedures of this study.
13. Suspected history of drug abuse or alcohol abuse
14. History of varicella or varicella-zoster virus (VZV) vaccination or participation in a
varicella or zoster vaccine clinical trial
15. Active antiviral therapy for varicella-zoster virus (VZV) within 1 week prior to the
first dose of investigational medication. (e.g., Acyclovir, Valacyclovir, Famciclovir,
Ganciclovir, etc.) (however, topical use is allowed)
16. Treatment with immunosuppressive or immunomodulatory agents or chronic steroid use
within 6 months prior to the first dose of investigational product.
? Immunosuppressants or immunomodulators: Azathioprine, Cyclosporine, Interferon,
G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine,
Methotrexate, Rapamycin, Leflunomide, etc.
? Systemic steroids: Prednisolone at a dose of =10 mg/day for more than 14 consecutive
days (topical, inhaled, nasal corticosteroids and eye drops are allowed at any dose).
17. Received any other investigational drug or received an investigational medical device
within 6 months of the screening visit.
18. A history of herpes zoster and/or varicella within 10 years of the screening visit, or
planned treatment for these conditions during the study period.
19. Have received or plan to receive any other vaccine within 4 weeks prior to or after
each dose of investigational product.
(Allow influenza vaccines and COVID-19 vaccines, but not vaccinations within 14 days
before or after receiving an investigational drug)
20. Treatment with immunoglobulins or blood-derived products within 3 months prior to the
first dose of investigational medicinal product or planned treatment during the study
period
21. Pregnant or lactating women
22. For any other reason deemed by the investigator to be unsuitable as a patient in this
study
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