Phase
Condition
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Shingles
Treatment
CVI-VZV-001
Shingrix
Clinical Study ID
Ages 50-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy adults over 50 years old and under 65 years old
Those who voluntarily decided to participate and gave written consent after hearingand understanding the detailed explanation of this clinical trial
Women with childbearing potential and those who agree to use the contraceptivemethod* 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, doubleblock method (cervical cap, use with contraceptive diaphragm)
Women of childbearing potential with negative result at pregnancy test beforevaccination for clinical trials.
Exclusion
Exclusion Criteria:
Those with a past history of shingles before screening
Persons with hypersensitivity to clinical investigational products or theingredients of clinical investigational products
Those with thrombocytopenia or other coagulation disorders who should not receiveintramuscular injections, or those receiving anticoagulant therapy*
*Anticoagulant therapy: Continuous use of anticoagulants such as coumarin/warfarinor new oral anticoagulants/antiplatelet agents
Those with a history of immune dysfunction, including immunodeficiency disease
Those suffering from chronic underlying diseases that, in the opinion of theinvestigator, may interfere with the progress and completion of this clinical trial
Those with a history of excessive alcohol consumption or drug addiction
Persons with a history of serious adverse events, allergies or hypersensitivityreactions related to vaccination (e.g. anaphylaxis, Guillain-Barré Syndrome)
Those with a history of malignant tumor
Those who developed a fever (tympanic membrane temperature of 38.0°C or higher)within 3 days prior to the first vaccination of clinical investigational product,suffered from a febrile illness on the day of vaccination, or suffered from adisease with moderate or more acute symptoms (mild illness without fever) (e.g. Ifyou have mild diarrhoea, mild upper respiratory infection), you can participate inthe clinical trial at the discretion of the investigator.)
Those who have received chickenpox or shingles vaccine before screening
Those who have participated in past chickenpox or shingles vaccine clinical trials
Those who have been vaccinated with another vaccine within 4 weeks prior to thefirst injection of the investigational product, or who plan to be vaccinated withanother vaccine by 48 weeks after the second injection of the investigationalproduct (however, seasonal or pandemic flu) (inactivated and subunit influenzavaccine and COVID-19 vaccine for prevention of flu) are contraindicated only within 2 weeks before and after vaccination of each clinical investigational product)
Those who have received blood products or immunoglobulin within 3 months prior toreceiving the first clinical investigational product, or those who plan toadminister it during the clinical trial period
Those who have received immunosuppressants, immunomodulating drugs, other cytotoxicanticancer drugs that may affect immunity, or have experienced radiation therapywithin 6 months prior to receiving the first clinical investigational product.
Those who have experienced systemic steroid administration within 3 months prior toreceiving the first clinical investigation drug (those who are taking a dose of 20mg/day or more based on prednisone continuously for more than 2 weeks) However,topical, inhalation ( Inhaled, intranasal, intra-articular, and intra-bursaladministration is permitted regardless of dosage.
Organ transplant or hematopoietic stem cell transplant patients
Those with positive virus test results (HCV Ab, HBsAg, HIV Ab) performed atscreening
Persons with clinically significant abnormalities in tests performed duringscreening (clinical laboratory tests, electrocardiogram, vital signs, etc.)
Those taking antiviral drugs (Acyclovir, Valacyclovir, Famciclovir, Ganciclovir,etc.) known to be effective against varicella-zoster virus at the time of screening (topical use of antiviral drugs is permitted)
Those with a history of active tuberculosis
A person who has received another clinical investigational product or applied aclinical trial medical device within 6 months before participating in a clinicaltrial
Pregnant or lactating women
If the investigator determines that the subject is unsuitable for this clinicaltrial for other reasons
Study Design
Study Description
Connect with a study center
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu 03312
Korea, Republic ofActive - Recruiting
Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do 13496
Korea, Republic ofActive - Recruiting
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