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Varicella Zoster Virus InfectionPhase 1NCT06409494

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

A Phase 1 study testing EuHZV and Shingrix in people with Varicella Zoster Virus Infection and Herpes Zoster, run by EuBiologics Co.,Ltd at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 69 yearsHealthy volunteers can take part
What is being tested?
EuHZV and Shingrix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSouth Korea
Study dates
15 Jul 2024to 31 May 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of serious adverse events, serious allergic reactions, or serious hypersensitivity reactions related to vaccination.
  • History of platelet-related or hemorrhagic disease (such as major venous and/or arterial thrombosis with thrombocytopenia), or history of excessive bleeding or bruising after intramuscular injection or venipuncture, or receiving anticoagulant therapy (except that patients may participate if they are using low-dose anticoagulants (e.g., aspirin <100 mg/day) as determined by the investigator).
  • History of systemic urticaria within 5 years prior to the first dose of investigational drug.
  • Have a history of hereditary or idiopathic angioneurotic edema
  • History of organ or bone marrow transplantation
  • History of dependent use of antipsychotics or narcotic analgesics within 6 months prior to the first dose of study medication, or psychiatric or social conditions that, in the opinion of the investigator, would make it difficult to comply with the procedures of this study.
  • Suspected history of drug abuse or alcohol abuse
  • History of varicella or varicella-zoster virus (VZV) vaccination or participation in a varicella or zoster vaccine clinical trial
  • Active antiviral therapy for varicella-zoster virus (VZV) within 1 week prior to the first dose of investigational medication. (e.g., Acyclovir, Valacyclovir, Famciclovir, Ganciclovir, etc.) (however, topical use is allowed)
  • Treatment with immunosuppressive or immunomodulatory agents or chronic steroid use within 6 months prior to the first dose of investigational product.
  • ① Immunosuppressants or immunomodulators: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate, Rapamycin, Leflunomide, etc.
  • ② Systemic steroids: Prednisolone at a dose of ≥10 mg/day for more than 14 consecutive days (topical, inhaled, nasal corticosteroids and eye drops are allowed at any dose).
  • Received any other investigational drug or received an investigational medical device within 6 months of the screening visit.
  • A history of herpes zoster and/or varicella within 10 years of the screening visit, or planned treatment for these conditions during the study period.
  • Have received or plan to receive any other vaccine within 4 weeks prior to or after each dose of investigational product.
  • (Allow influenza vaccines and COVID-19 vaccines, but not vaccinations within 14 days before or after receiving an investigational drug)
  • Treatment with immunoglobulins or blood-derived products within 3 months prior to the first dose of investigational medicinal product or planned treatment during the study period
  • Pregnant or lactating women
  • For any other reason deemed by the investigator to be unsuitable as a patient in this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul

Other trials in South Korea

About this study

Official title: A PhaseⅠ, Randomized, Observer-blinded, Active Comparator, First-in-human Clinical Trial to Evaluate Safety and Tolerability of Herpes Zoster Vaccine EuHZV in Healthy Adults Aged 50 to 69 Years

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.

Being tested
EuHZV, Shingrix
Keywords
EuHZV, HZV, Varicella Zoster Virus, Herpes Zoster
Medical subject headings
Varicella Zoster Virus Infection, Herpes Zoster, Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EuHZVBiological

    Drug(injection)

  • ShingrixBiological

    Drug(injection)

Study groups in NCT06409494
Study groupRoleWhat they receive
HZV-1ExperimentalBiological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Receives: Biological: EuHZV
HZV-2ExperimentalBiological: EuHZV Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Receives: Biological: EuHZV
ShingrixActive comparatorBiological: Shingrix Healthy adults received 0.5mL single intramuscular dose on Visit 2(Day 0) and Visit 4(day 56).
Receives: Biological: Shingrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of immediate adverse events

    local and systemic AEs

    Measured: within 30 minutes post vaccination

  2. Occurrence of solicited adverse events

    local and systemic AEs

    Measured: within 7 days post vaccination

  3. Occurrence of unsolicited adverse events

    local and systemic AEs

    Measured: within 52 weeks post vaccination

  4. Occurrence of serious adverse events

    local and systemic AEs

    Measured: within 52 weeks post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start15 Jul 2024
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06409494
Sponsor's protocol ID
EuHZV_101
Status last verified
Jun 2025
First submitted
7 May 2024
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EuHZV and Shingrix in people with Varicella Zoster Virus Infection and Herpes Zoster, run by EuBiologics Co.,Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of immediate adverse events (time frame: within 30 minutes post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06409494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

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