A Multicenter, Active-controlled, Open-label Phase I Study to Assess Safety and Tolerability and to Explore Immunogenicity of CVI-VZV-001 Vaccine in Healthy Adults Aged 50 to 64 Years
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 64
Healthy Volunteers: t
View:
• Healthy adults over 50 years old and under 65 years old
• Those who voluntarily decided to participate and gave written consent after hearing and understanding the detailed explanation of this clinical trial
• 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)
• Women of childbearing potential with negative result at pregnancy test before vaccination for clinical trials.
Locations
Other Locations
Republic of Korea
Bundang CHA General Hospital
RECRUITING
Seongnam-si
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Contact Information
Primary
Gabsoon Noh
gsnoh75@chamc.co.kr
+82318817341
Time Frame
Start Date:2023-03-15
Estimated Completion Date:2025-03-21
Participants
Target number of participants:32
Treatments
Experimental: Group 1
Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.37 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Experimental: Group 2
Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Experimental: Group 3
Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.75 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Active_comparator: Active Control
Shingrix 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses