Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years

Launched by EUBIOLOGICS CO.,LTD · May 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of two new vaccines, HZV-1 and HZV-2, designed to protect against infections caused by the varicella zoster virus, which can lead to shingles. It is open to healthy adults aged 50 to 69 years who are willing to join the study and provide written consent. To participate, individuals must have a body mass index (BMI) between 18 and 30 and agree to use effective contraception during the trial.

Participants in this study can expect to receive the vaccines and will be monitored for any side effects. It’s important to note that certain health conditions, such as significant heart or lung diseases, recent infections, or history of certain allergic reactions, may prevent someone from participating. This trial is actively recruiting, so if you or someone you know fits the eligibility criteria and is interested in helping advance medical research, you might consider reaching out for more details.

Gender

ALL

Eligibility criteria

• 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.
• • ④ 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).
• • ⑤ Autoimmune diseases including autoimmune hypothyroidism and psoriasis
• • ⑥ Immunodeficiency diseases
• • ⑦ Thrombosis at uncommon sites, such as cerebral venous sinus thrombosis and visceral venous thrombosis, and heparin-induced thrombocytopenia or antiphospholipid syndrome
• • ⑧ Capillary leak syndrome
• • ⑨ 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.
• • ① Immunosuppressants or immunomodulators: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide, etc.
• • ② 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