Actively Recruiting
Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
Led by CHA Vaccine Institute Co., Ltd. · Updated on 2024-11-19
32
Participants Needed
2
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
CONDITIONS
Official Title
Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 50 to under 65 years
- Voluntarily agreed to participate and provided written informed consent
- Women of childbearing potential agree to use approved contraception methods up to 3 months after final vaccination
- Women of childbearing potential have a negative pregnancy test before vaccination
You will not qualify if you...
- History of shingles before screening
- Allergy or hypersensitivity to study vaccines or their ingredients
- Bleeding disorders or ongoing anticoagulant therapy that contraindicates intramuscular injections
- History of immune dysfunction or immunodeficiency diseases
- Chronic diseases that may interfere with study participation
- History of excessive alcohol use or drug addiction
- Serious adverse reactions to previous vaccinations (e.g., anaphylaxis, Guillain-Barré Syndrome)
- History of malignant tumors
- Recent fever or acute illness at vaccination time
- Previous chickenpox or shingles vaccination
- Participation in prior chickenpox or shingles vaccine trials
- Vaccination with other vaccines within 4 weeks before first study injection or planned vaccination within 48 weeks after second injection, except seasonal or pandemic flu vaccines with timing restrictions
- Receipt of blood products or immunoglobulin within 3 months before first vaccination or planned during study
- Use of immunosuppressive or cytotoxic drugs or radiation therapy within 6 months before first vaccination
- Systemic steroid use at immunosuppressive doses within 3 months before first vaccination (topical and inhaled steroids allowed)
- History of organ or stem cell transplant
- Positive viral tests (HCV, HBV, HIV) at screening
- Significant clinical abnormalities during screening tests
- Use of antiviral drugs effective against varicella-zoster virus at screening (topical allowed)
- History of active tuberculosis
- Participation in other clinical trials with investigational products or devices within 6 months
- Pregnant or breastfeeding women
- Other investigator-determined unsuitability for the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, South Korea, 03312
Actively Recruiting
2
Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
Research Team
G
Gabsoon Noh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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