Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-64
SponsorCHA Vaccine Institute Co., Ltd.
About this trial
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Those with a past history of shingles before screening
Persons with hypersensitivity to clinical investigational products or the ingredients of clinical investigational products
Those with thrombocytopenia or other coagulation disorders who should not receive intramuscular injections, or those receiving anticoagulant therapy*
Those with a history of immune dysfunction, including immunodeficiency disease
Trial design
Treatments tested in this trial
- CVI-VZV-001
- Shingrix
Treatment groups
32 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov