A Phase 1 interventional study of EuHZV and Shingrix in Varicella Zoster Virus Infection and Herpes Zoster, sponsored by EuBiologics Co.,Ltd. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by EuBiologics Co.,Ltd · Phase 1, Interventional, and Prevention
Phase 1 clinical trial to evaluate the safety of HZV-1 and HZV-2 vaccines in healthy adults aged 50 to 69 years who have voluntarily given written consent to participate in this study.
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).
Exclusion Criteria:
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
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).
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)
Biological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Biological: EuHZV
Biological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Biological: EuHZV
Biological: Shingrix Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Biological: Shingrix
Drug(injection)
Drug(injection)
Occurrence of immediate adverse events
local and systemic AEs
Time frame: within 30 minutes post vaccination
Occurrence of solicited adverse events
local and systemic AEs
Time frame: within 7 days post vaccination
Occurrence of unsolicited adverse events
local and systemic AEs
Time frame: within 52 weeks post vaccination
Occurrence of serious adverse events
local and systemic AEs
Time frame: within 52 weeks post vaccination
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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EuBiologics Co.,Ltd