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

Last updated: November 16, 2024
Sponsor: CHA Vaccine Institute Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Shingles

Treatment

CVI-VZV-001

Shingrix

Clinical Study ID

NCT06137755
CVI-VZV-001-CT2101
  • Ages 50-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy adults over 50 years old and under 65 years old

  2. Those who voluntarily decided to participate and gave written consent after hearingand understanding the detailed explanation of this clinical trial

  3. 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)

  4. Women of childbearing potential with negative result at pregnancy test beforevaccination for clinical trials.

Exclusion

Exclusion Criteria:

  1. Those with a past history of shingles before screening

  2. Persons with hypersensitivity to clinical investigational products or theingredients of clinical investigational products

  3. 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

  1. Those with a history of immune dysfunction, including immunodeficiency disease

  2. Those suffering from chronic underlying diseases that, in the opinion of theinvestigator, may interfere with the progress and completion of this clinical trial

  3. Those with a history of excessive alcohol consumption or drug addiction

  4. Persons with a history of serious adverse events, allergies or hypersensitivityreactions related to vaccination (e.g. anaphylaxis, Guillain-Barré Syndrome)

  5. Those with a history of malignant tumor

  6. 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.)

  7. Those who have received chickenpox or shingles vaccine before screening

  8. Those who have participated in past chickenpox or shingles vaccine clinical trials

  9. 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)

  10. 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

  11. 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.

  12. 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.

  13. Organ transplant or hematopoietic stem cell transplant patients

  14. Those with positive virus test results (HCV Ab, HBsAg, HIV Ab) performed atscreening

  15. Persons with clinically significant abnormalities in tests performed duringscreening (clinical laboratory tests, electrocardiogram, vital signs, etc.)

  16. 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)

  17. Those with a history of active tuberculosis

  18. A person who has received another clinical investigational product or applied aclinical trial medical device within 6 months before participating in a clinicaltrial

  19. Pregnant or lactating women

  20. If the investigator determines that the subject is unsuitable for this clinicaltrial for other reasons

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: CVI-VZV-001
Phase: 1
Study Start date:
March 15, 2023
Estimated Completion Date:
March 21, 2025

Study Description

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

Connect with a study center

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Eunpyeong-gu 03312
    Korea, Republic of

    Active - Recruiting

  • Bundang CHA General Hospital

    Seongnam-si, Gyeonggi-do 13496
    Korea, Republic of

    Active - Recruiting

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