Actively Recruiting
Safety and Immunogenicity of CVI-VZV-001 Vaccine Compared to Shingrix for Prevention of Herpes Zoster in Healthy Adults Aged 50 to 64 Years
Led by CHA Vaccine Institute Co., Ltd. · Updated on 2024-11-19
32
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of an investigational vaccine called CVI-VZV-001 for preventing herpes zoster (shingles) in healthy adults aged 50 to 64 years. This Phase I, open-label study compares different doses of CVI-VZV-001 with an active control vaccine called Shingrix. The study aims to explore how well the vaccine is tolerated and how it stimulates the immune system. Participants will receive two intramuscular injections at the start of the study and eight weeks later. Four groups are involved: three different dose levels of CVI-VZV-001 (0.37 mL, 0.50 mL, and 0.75 mL) and one group receiving the Shingrix vaccine (0.50 mL). Each participant receives two doses during the study period. During the study, participants will be monitored closely for immediate reactions within 30 minutes after vaccination and for local and systemic side effects for six days after each vaccination. Unsolicited symptoms will be tracked up to four weeks after the second dose, with serious and medically attended adverse events monitored for up to 48 weeks. Researchers will assess immune responses before and after vaccinations, including at 4, 24, and 48 weeks post-second dose, using laboratory tests and physical exams to evaluate safety and immune activity.
CONDITIONS
Brief 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 over 50 and under 65 years
- Voluntary participation with written informed consent
- Women of childbearing potential must agree to use contraception up to 3 months after the final vaccination
- Women of childbearing potential must have a negative pregnancy test before vaccination
You will not qualify if you...
- History of shingles before screening
- Hypersensitivity to the investigational vaccine or its ingredients
- Thrombocytopenia, coagulation disorders, or ongoing anticoagulant therapy
- History of immune dysfunction or immunodeficiency disease
- Chronic illnesses that may interfere with study participation
- History of excessive alcohol use or drug addiction
- Previous serious vaccine-related adverse events or allergies
- History of malignant tumors
- Fever or febrile illness near vaccination time
- Prior receipt of chickenpox or shingles vaccine
- Participation in previous chickenpox or shingles vaccine trials
- Vaccination with another vaccine within 4 weeks before first dose or planned vaccination within 48 weeks after second dose (with some exceptions)
- Receipt of blood products or immunoglobulin within 3 months before first dose or planned during study
- Use of immunosuppressants, immunomodulating drugs, or radiation therapy within 6 months before first dose
- Systemic steroid use at high dose within 3 months before first dose
- Organ or hematopoietic stem cell transplant
- Positive virus tests (HCV Ab, HBsAg, HIV Ab) at screening
- Significant abnormalities in screening tests
- Use of antiviral drugs effective against varicella-zoster virus at screening
- History of active tuberculosis
- Participation in other clinical trials or use of investigational devices within 6 months before study
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive two doses of the investigational vaccine or comparator vaccine by intramuscular injection at Baseline and Week 8.
2 vaccination visits plus multiple follow-up visits for safety and immune response assessments
Duration - 48 weeks post second vaccination
Participants are monitored for safety and immune response up to 48 weeks after the second vaccination.
Several visits at 4, 24, and 48 weeks after the second vaccination
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
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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