NCT06137755 Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
| NCT ID | NCT06137755 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | CHA Vaccine Institute Co., Ltd. |
| Condition | Vaccine-Preventable Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2025-03-21 |
Trial Parameters
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Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
Eligibility Criteria
Inclusion Criteria: 1. Healthy adults over 50 years old and under 65 years old 2. Those who voluntarily decided to participate and gave written consent after hearing and understanding the detailed explanation of this clinical trial 3. Women with childbearing potential and those who agree to use the contraceptive method\* permitted up to 3 months after the final vaccination for clinical trials (\* Combination use such as hormonal contraception, intrathyroidal device (IUD (Intrauterine device) or IUS (Intrauterine system), vasectomy, tubal stomy, double block method (cervical cap, use with contraceptive diaphragm) 4. Women of childbearing potential with negative result at pregnancy test before vaccination for clinical trials. Exclusion Criteria: 1. Those with a past history of shingles before screening 2. Persons with hypersensitivity to clinical investigational products or the ingredients of clinical investigational products 3. Those with thrombocytopenia or other coagulation disorders