Herpes ZosterPhase 2NCT07481604
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
A Phase 2 study testing Shingrix and CVI-VZV-001 in people with Herpes Zoster, run by Aribio Lab Co., Ltd. at 7 sites in South Korea.
Trial summary
To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Shingrix and CVI-VZV-001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 17 Apr 2026to Jan 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Healthy adults aged 50 years or older
- Able to understand the study procedures and provide written informed consent
- Females and males of reproductive potential must agree to use medically acceptable contraception until 3 months after the last vaccination
- Females of childbearing potential must have a negative pregnancy test prior to vaccination
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- History of herpes zoster prior to screening
- History of severe allergic reaction to vaccines or vaccine components
- Known immunodeficiency or immune dysfunction
- Prior vaccination with varicella or herpes zoster vaccine
- Use of immunosuppressive therapy or systemic steroids that may affect immune response
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- Positive test for HCV, HBV, or HIV at screening
- Pregnant or breastfeeding women
- Any medical condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Kyungpook National University Chilgok Hospital
Daegu, Daegu
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, Seoul, 03312
Chung-Ang University Hospital
Seoul, Seoul
Ewha Womans University Seoul Hospital
Seoul, Seoul
Yongin Severance Hospital, Yonsei University Health System
Yongin, Gyeonggi-do
About this study
Official title: A Multicenter, Active-controlled, Randomized, Double Blinded, Parallel, Phase II Study to Assess the Immunogenicity and Safety of CVI-VZV-001 in Healthy Adults Aged 50 Years and Above
To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.
- Conditions
- Herpes Zoster
- Being tested
- Shingrix, CVI-VZV-001
- Keywords
- Herpes Zoster Vaccine, Shingles, Varicella Zoster Virus, Immunogenicity
- Medical subject headings
- Herpes Zoster, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixBiological
Licensed herpes zoster vaccine used as an active comparator.
CVI-VZV-001Biological
Investigational herpes zoster vaccine.
| Study group | Role | What they receive |
|---|---|---|
| CVI-VZV-001 Low Dose | Experimental | Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the low dose level administered intramuscularly on Day 0 and Week 8. Receives: Biological: CVI-VZV-001 |
| CVI-VZV-001 High Dose | Experimental | Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the high dose level administered intramuscularly on Day 0 and Week 8. Receives: Biological: CVI-VZV-001 |
| Shingrix | Active comparator | Participants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody
Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.
Measured: Baseline to 4 weeks after the second vaccination
Secondary outcomes (5)
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points
Geometric mean fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline.
Measured: Before the second vaccination and at 8 and 24 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody
Geometric mean concentration (GMC) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.
Measured: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Vaccine Response Rate (VRR) of Anti-VZV gE Antibody
Proportion of participants achieving a predefined vaccine response in anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.
Measured: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Polyfunctional CD4+ T Cell Response
Frequency of polyfunctional CD4+ T cells defined as CD4+ T cells producing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L [CD154]) following stimulation with VZV glycoprotein E peptides.
Measured: 4 and 8 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV Antibody
Geometric mean concentration (GMC) of anti-varicella-zoster virus (VZV) antibodies measured by ELISA.
Measured: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start17 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aribio Lab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481604
- Sponsor's protocol ID
- CVI-VZV-001-CT2501-B
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Active-controlled, Randomized, Double Blinded, Parallel, Phase II Study to Assess the Immunogenicity and Safety of CVI-VZV-001 in Healthy Adults Aged 50 Years and Above
- ClinicalTrials.gov ID
- NCT07481604
- Acronym / sponsor ID
- CVI-VZV-001-CT2501-B
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster Vaccine, Shingles, Varicella Zoster Virus, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Aribio Lab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CVI-VZV-001 Low Dose | Experimental | Biological: CVI-VZV-001Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the low dose level administered intramuscularly on Day 0 and Week 8. |
| CVI-VZV-001 High Dose | Experimental | Biological: CVI-VZV-001Participants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the high dose level administered intramuscularly on Day 0 and Week 8. |
| Shingrix | Active comparator | Biological: ShingrixParticipants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (9 listed)
- Participants meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShingrixLicensed herpes zoster vaccine used as an active comparator. | Biological | Shingrix |
| CVI-VZV-001Investigational herpes zoster vaccine. | Biological | CVI-VZV-001 High Dose, CVI-VZV-001 Low Dose |
Primary outcome
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody
Time frame: Baseline to 4 weeks after the second vaccination
Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.
5 secondary outcomes
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points
Time frame: Before the second vaccination and at 8 and 24 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody
Time frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Vaccine Response Rate (VRR) of Anti-VZV gE Antibody
Time frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Polyfunctional CD4+ T Cell Response
Time frame: 4 and 8 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV Antibody
Time frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shingrix and CVI-VZV-001 in people with Herpes Zoster, run by Aribio Lab Co., Ltd. at 7 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 5 inclusion and 9 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 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 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody (time frame: Baseline to 4 weeks after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 8 Nov 2026.