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

NCT06137755 | Recruiting Phase 1 DMC

• 1 other identifier: CVI-VZV-001-CT2101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Vaccine-Preventable Diseases; Herpes Zoster

Outcome Measures

Primary Outcomes (7)

• Immediate adverse events

  Occurrence of immediate adverse events

  within 30 minutes at each vaccination timepoint

• Solicited local and systemic signs and symptoms

  Occurrence, severity, and duration of solicited local injection site reactions for 7 days (Day 0-Day 6) following each vaccination. (i.e., pain, redness, swelling) Occurrence, severity, and duration of solicited systemic reactions for 7 days (Day 0-Day 6) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever)

  Day 0 - Day 6 for each vaccination timepoint

• Unsolicited signs and symptoms

  Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following the last vaccination

  Until Week 4 post the 2nd vaccination

• SAEs

  Occurrence of serious adverse events (SAEs)

  Until Week 48 post the 2nd vaccination

• MAAEs

  Occurrence of Medically attended adverse events(MAAEs)

  Until Week 48 post the 2nd vaccination

• AESIs

  Occurrence of adverse events (AEs) of special interest

  Until Week 48 post the 2nd vaccination

• Safety as measured by clinical laboratory test, vial sign and physical examination parameters

  Occurrence, intensity, and relationship to vaccination of clinically significant adverse events

  Until Week 4 post the 2nd vaccination

Secondary Outcomes (2)

• Humoral immune response before the first and second vaccinations of investigational drugs and at 4, 24, and 48 weeks after the second vaccination.

  Pre vaccinations(Day0, week 8) of 1st and 2nd vaccination, and at 4, 24, and 48 weeks post the 2nd vaccination

• Cell-mediated immunity (CMI) immune response before the first and second vaccinations of investigational drugs and at 4, 24, and 48 weeks after the second vaccination.

  Pre vaccinations(Day0, week 8) of 1st and 2nd vaccination, and at 4, 24, and 48 weeks post the 2nd vaccination

Study Arms (4)

Group 1

EXPERIMENTAL

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

Biological: CVI-VZV-001

Group 2

EXPERIMENTAL

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

Biological: CVI-VZV-001

Group 3

EXPERIMENTAL

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

Biological: CVI-VZV-001

Active Control

ACTIVE COMPARATOR

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

Biological: Shingrix

Interventions

CVI-VZV-001 BIOLOGICAL

Investigational Product

Group 1; Group 2; Group 3

Shingrix BIOLOGICAL

Investigational Product

Active Control

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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\*
• \*Anticoagulant therapy: Continuous use of anticoagulants such as coumarin/warfarin or 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 the investigator, 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 hypersensitivity reactions 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 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.)
• 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 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)
• 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
• 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.

Sponsors & Collaborators

• CHA Vaccine Institute Co., Ltd.: lead

Study Sites (2)

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

Seoul, Eunpyeong-gu, 03312, South Korea

RECRUITING

Bundang CHA General Hospital

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Herpes Zoster

Condition Hierarchy (Ancestors)

Infections; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases

Study Officials

• Jeonghyeon Choi

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabsoon Noh

CONTACT

+82318817341; gsnoh75@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: March 15, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

KR (2)