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

NCT ID: NCT06137755

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-03-21

Brief Summary

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

Detailed 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

Conditions

Vaccine-Preventable Diseases; Herpes Zoster

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.37 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses

Group Type: EXPERIMENTAL

CVI-VZV-001

Intervention Type: BIOLOGICAL

Investigational Product

Group 2

Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses

Group Type: EXPERIMENTAL

CVI-VZV-001

Intervention Type: BIOLOGICAL

Investigational Product

Group 3

Recombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.75 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses

Group Type: EXPERIMENTAL

CVI-VZV-001

Intervention Type: BIOLOGICAL

Investigational Product

Active Control

Shingrix 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses

Group Type: ACTIVE_COMPARATOR

Shingrix

Intervention Type: BIOLOGICAL

Investigational Product

Interventions

CVI-VZV-001

Investigational Product

Intervention Type: BIOLOGICAL

Shingrix

Investigational Product

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 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.

Exclusion Criteria

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)

8. Those with a history of malignant tumor

9. 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 a disease with moderate or more acute symptoms (mild illness without fever) (e.g. If you have mild diarrhoea, mild upper respiratory infection), you can participate in the clinical trial at the discretion of the investigator.)

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

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

12. Those who have been vaccinated with another vaccine within 4 weeks prior to the first injection of the investigational product, or who plan to be vaccinated with another vaccine by 48 weeks after the second injection of the investigational product (however, seasonal or pandemic flu) (inactivated and subunit influenza vaccine and COVID-19 vaccine for prevention of flu) are contraindicated only within 2 weeks before and after vaccination of each clinical investigational product)

13. Those who have received blood products or immunoglobulin within 3 months prior to receiving the first clinical investigational product, or those who plan to administer it during the clinical trial period

14. Those who have received immunosuppressants, immunomodulating drugs, other cytotoxic anticancer drugs that may affect immunity, or have experienced radiation therapy within 6 months prior to receiving the first clinical investigational product.

15. Those who have experienced systemic steroid administration within 3 months prior to receiving the first clinical investigation drug (those who are taking a dose of 20 mg/day or more based on prednisone continuously for more than 2 weeks) However, topical, inhalation ( Inhaled, intranasal, intra-articular, and intra-bursal administration is permitted regardless of dosage.

16. Organ transplant or hematopoietic stem cell transplant patients

17. Those with positive virus test results (HCV Ab, HBsAg, HIV Ab) performed at screening

18. Persons with clinically significant abnormalities in tests performed during screening (clinical laboratory tests, electrocardiogram, vital signs, etc.)

19. 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)

20. Those with a history of active tuberculosis

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

22. Pregnant or lactating women

23. If the investigator determines that the subject is unsuitable for this clinical trial for other reasons

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHA Vaccine Institute Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeonghyeon Choi

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, Eunpyeong-gu, South Korea

Site Status: RECRUITING

Bundang CHA General Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Gabsoon Noh

Role: CONTACT

gsnoh75@chamc.co.kr

+82318817341

Facility Contacts

Jeonghyeon Choi

Role: primary

Jonghoon Kim

Role: primary

Other Identifiers

CVI-VZV-001-CT2101

Identifier Type: -

Identifier Source: org_study_id