Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years

NCT06409494 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: EuHZV_101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 clinical trial to evaluate the safety of HZV-1 and HZV-2 vaccines in healthy adults aged 50 to 69 years who have voluntarily given written consent to participate in this study.

Conditions

Varicella Zoster Virus Infection; Herpes Zoster

Keywords

EuHZV; HZV; Varicella Zoster Virus; Herpes Zoster

Outcome Measures

Primary Outcomes (4)

• Occurrence of immediate adverse events

  local and systemic AEs

  within 30 minutes post vaccination

• Occurrence of solicited adverse events

  local and systemic AEs

  within 7 days post vaccination

• Occurrence of unsolicited adverse events

  local and systemic AEs

  within 52 weeks post vaccination

• Occurrence of serious adverse events

  local and systemic AEs

  within 52 weeks post vaccination

Study Arms (3)

HZV-1

EXPERIMENTAL

Biological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).

Biological: EuHZV

HZV-2

EXPERIMENTAL

Biological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).

Biological: EuHZV

Shingrix

ACTIVE COMPARATOR

Biological: Shingrix Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).

Biological: Shingrix

Interventions

EuHZV BIOLOGICAL

Drug(injection)

HZV-1; HZV-2

Shingrix BIOLOGICAL

Drug(injection)

Shingrix

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult men and women between the ages of 50 and 69 years old
• Have a body mass index (BMI) of at least 18 kg/m2 and no more than 30 kg/m2 at the screening visit
• Men and women who agree to use a highly effective method of contraception (\*See section 8.7 of the protocol) (however, not women of childbearing age or men who do not have a spouse (partner) may be enrolled regardless of method of contraception).
• Women of childbearing potential: Practiced a highly effective method of birth control for 4 weeks prior to the first dose of study medication and agreed to continue to use a highly effective method of birth control for the duration of the study (up to 3 months after the last dose of study medication).
• Men who have a spouse (partner): Has agreed to use a highly effective method of birth control for the duration of the study (up to 3 months after the last dose of study medication).
• Agree to refrain from donating blood and transfusions (whole blood, plasma components, platelet components, platelet-plasma components) for the duration of the study.
• After receiving and understanding a detailed explanation of this clinical trial, voluntarily decide to participate and give written consent.
• For women of childbearing potential, a negative pregnancy test prior to receiving the investigational drug.

You may not qualify if:

• Clinically significant abnormalities on clinical laboratory tests, electrocardiogram (ECG), or chest x-ray at screening.
• Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test results at screening.
• Active pulmonary infection within 14 days prior to the first dose of investigational medicinal product, or any other significant infectious disease that, in the opinion of the investigator, would render the subject ineligible for participation in the study.
• Have had an acute febrile illness of 38 degrees or greater within 3 days prior to the first dose of investigational drug
• Have any of the following conditions, or any serious medical or neuropsychiatric condition that, in the opinion of the investigator, would make them ineligible to participate in this study.
• Respiratory disease: asthma, chronic obstructive pulmonary disease (COPD), active tuberculosis, or latent tuberculosis.
• Serious cardiovascular disease: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, myocarditis, pericarditis, etc.
• Nervous system disease: epilepsy, seizures (within 3 years prior to first dose of investigational drug), migraine, stroke, cerebral lesions, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, dementia, etc.
• ④ History of malignancy within 5 years prior to the first dose of investigational drug and a history of malignant disease with a high risk of recurrence (skin basal cell carcinoma and squamous cell carcinoma with a minimal risk of recurrence based on clinical judgment may be eligible).
• ⑤ Autoimmune diseases including autoimmune hypothyroidism and psoriasis
• ⑥ Immunodeficiency diseases
• ⑦ Thrombosis at uncommon sites, such as cerebral venous sinus thrombosis and visceral venous thrombosis, and heparin-induced thrombocytopenia or antiphospholipid syndrome
• ⑧ Capillary leak syndrome
• ⑨ Other hepatobiliary, renal, endocrine, urinary, or musculoskeletal diseases deemed clinically significant by the investigator
• History of allergic reactions or hypersensitivity to any of the components of the investigational drug.

Sponsors & Collaborators

• EuBiologics Co.,Ltd: lead

Study Sites (1)

The Catholic University of Eunpyeong St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: July 15, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

KR (1)