RecruitingVaccine-Preventable DiseasesHerpes Zoster

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above

Eligible age

50–64 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

Yes

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.

Sponsor: Aribio Lab Co., Ltd.

✓ 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.

✕ 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 who should not receive intramuscular injections, or those receiving anticoagulant therapy\*
✕ \*Anticoagulant therapy: Continuous use of anticoagulants such as coumarin/warfarin or new oral anticoagulants/antiplatelet agents
✕ 4. Those with a history of immune dysfunction, including immunodeficiency disease
✕ 5. Those suffering from chronic underlying diseases that, in the opinion of the investigator, may interfere with the progress and completion of this clinical trial
✕ 6. Those with a history of excessive alcohol consumption or drug addiction
✕ 7. Persons with a history of serious adverse events, allergies or hypersensitivity reactions related to vaccination (e.g. anaphylaxis, Guillain-Barré Syndrome)

Source: ClinicalTrials.gov · NCT06137755 · last updated 2024-11-19