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AzTrials

Vaccine-Preventable DiseasesPhase 1NCT06137755

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

A Phase 1 study testing CVI-VZV-001 and Shingrix in people with Vaccine-Preventable Diseases and Herpes Zoster, run by Aribio Lab Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Vaccine-Preventable Diseases, Herpes Zoster
What is being tested?
CVI-VZV-001 and Shingrix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesSouth Korea
Study dates
15 Mar 2023to 21 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.
  • 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.
  • Organ transplant or hematopoietic stem cell transplant patients
  • Those with positive virus test results (HCV Ab, HBsAg, HIV Ab) performed at screening
  • Persons with clinically significant abnormalities in tests performed during screening (clinical laboratory tests, electrocardiogram, vital signs, etc.)
  • 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)
  • Those with a history of active tuberculosis
  • 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
  • Pregnant or lactating women
  • If the investigator determines that the subject is unsuitable for this clinical trial for other reasons

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Bundang CHA General Hospital

    Seongnam-si, Gyeonggi-do, 13496

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

    Seoul, Eunpyeong-gu, 03312

Other trials in South Korea

About this study

Official title: 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

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

Read the 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

Being tested
CVI-VZV-001, Shingrix
Medical subject headings
Vaccine-Preventable Diseases, Herpes Zoster

What participants receive

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

  • CVI-VZV-001Biological

    Investigational Product

  • ShingrixBiological

    Investigational Product

Study groups in NCT06137755
Study groupRoleWhat they receive
Group 1ExperimentalRecombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.37 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Receives: Biological: CVI-VZV-001
Group 2ExperimentalRecombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Receives: Biological: CVI-VZV-001
Group 3ExperimentalRecombinant Herpes Zoster Vaccine(CVI-VZV-001) 0.75 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Receives: Biological: CVI-VZV-001
Active ControlActive comparatorShingrix 0.50 mL per dose, Intramuscular injection at Baseline, Week 8 / total 2 doses
Receives: Biological: Shingrix

What is being measured

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

  1. Immediate adverse events

    Occurrence of immediate adverse events

    Measured: within 30 minutes at each vaccination timepoint

  2. 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)

    Measured: Day 0 - Day 6 for each vaccination timepoint

  3. Unsolicited signs and symptoms

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

    Measured: Until Week 4 post the 2nd vaccination

  4. SAEs

    Occurrence of serious adverse events (SAEs)

    Measured: Until Week 48 post the 2nd vaccination

  5. MAAEs

    Occurrence of Medically attended adverse events(MAAEs)

    Measured: Until Week 48 post the 2nd vaccination

  6. AESIs

    Occurrence of adverse events (AEs) of special interest

    Measured: Until Week 48 post the 2nd vaccination

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

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

    Measured: Until Week 4 post the 2nd vaccination

Secondary outcomes (2)

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

    Anti-VZV antibody titer, Anti-VZV glycoprotein ELISA

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

  2. 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.

    IFN-gamma ELISpot, Polyfunctional T cell(ICS)

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

Timeline

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

  1. First posted18 Nov 2023
  2. Study start15 Mar 2023
  3. Primary completion21 Jan 2025
  4. Study completion21 Jan 2025

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137755
Sponsor's protocol ID
CVI-VZV-001-CT2101
Status last verified
Jul 2026
First submitted
14 Nov 2023
Last updated
28 Oct 2026
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 CVI-VZV-001 and Shingrix in people with Vaccine-Preventable Diseases and Herpes Zoster, run by Aribio Lab Co., Ltd. at 2 sites 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 4 inclusion and 24 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immediate adverse events (time frame: within 30 minutes at each vaccination timepoint). The study lists 7 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 NCT06137755.

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 28 Oct 2026.

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