ClinicalTrials.gg
Active, not recruitingNCT06409494Updated Jun 17, 2025

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

A Phase 1 interventional study of EuHZV and Shingrix in Varicella Zoster Virus Infection and Herpes Zoster, sponsored by EuBiologics Co.,Ltd. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by EuBiologics Co.,Ltd · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
50 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Varicella Zoster Virus Infection
  • Herpes Zoster

Keywords

  • EuHZV
  • HZV
  • Varicella Zoster Virus
  • Herpes Zoster
03

In context

Varicella Zoster Virus Infection

17 studies on the registry are indexed under Varicella Zoster Virus Infection; 3 are open to participants now.

This study's enrollment of 72 is below the median of 86 across 10 interventional studies indexed under Varicella Zoster Virus Infection.

Browse Varicella Zoster Virus Infection studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult men and women between the ages of 50 and 69 years old
  2. Have a (BMI) of at least 18 kg/m2 and no more than 30 kg/m2 at the screening visit
  3. Men and women who agree to use a highly effective method of (*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 : 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).
  4. Agree to refrain from donating blood and transfusions (whole blood, plasma components, components, platelet-plasma components) for the duration of the study.
  5. After receiving and understanding a detailed explanation of this clinical trial, voluntarily decide to participate and give written consent.
  6. For women of childbearing potential, a negative pregnancy test prior to receiving the drug.

Exclusion criteria

Exclusion Criteria:

  1. abnormalities on clinical laboratory tests, (ECG), or chest x-ray at screening.
  2. Positive , , or (HIV) test results at screening.
  3. Active pulmonary infection within 14 days prior to the first dose of 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.
  4. Have had an acute febrile illness of 38 degrees or greater within 3 days prior to the first dose of investigational drug
  5. 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, (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 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 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

  6. History of allergic reactions or to any of the components of the investigational drug.
  7. History of serious adverse events, serious allergic reactions, or serious hypersensitivity reactions related to vaccination.
  8. History of -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).
  9. History of systemic urticaria within 5 years prior to the first dose of investigational drug.
  10. Have a history of hereditary or idiopathic angioneurotic edema
  11. History of organ or bone marrow transplantation
  12. 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.
  13. Suspected history of drug abuse or alcohol abuse
  14. History of varicella or varicella-zoster virus (VZV) vaccination or participation in a varicella or zoster vaccine clinical trial
  15. 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)
  16. Treatment with or immunomodulatory agents or chronic 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).

  17. Received any other investigational drug or received an investigational medical device within 6 months of the screening visit.
  18. 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.
  19. 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)

  20. 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
  21. Pregnant or lactating women
  22. For any other reason deemed by the investigator to be unsuitable as a patient in this study
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    HZV-1

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

    Biological: EuHZV

  • Experimental
    HZV-2

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

    Biological: EuHZV

  • Active comparator
    Shingrix

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

    Biological: Shingrix

Interventions

  • BiologicalEuHZV

    Drug(injection)

  • BiologicalShingrix

    Drug(injection)

06

What researchers measure

Primary outcomes

  1. Occurrence of immediate adverse events

    local and systemic AEs

    Time frame: within 30 minutes post vaccination

  2. Occurrence of solicited adverse events

    local and systemic AEs

    Time frame: within 7 days post vaccination

  3. Occurrence of unsolicited adverse events

    local and systemic AEs

    Time frame: within 52 weeks post vaccination

  4. Occurrence of serious adverse events

    local and systemic AEs

    Time frame: within 52 weeks post vaccination

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jul 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 10, 2024
StartActual
Jul 15, 2024
Primary completionEst.
Jul 31, 2025
CompletionEst.
May 31, 2026
Last update
Jun 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06409494
Lead sponsor
EuBiologics Co.,Ltd
Responsible party
Sponsor
First posted
May 10, 2024
Start date
Jul 15, 2024
Primary completion
Jul 31, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Jun 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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