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
- Apr 2026to Jan 2027
- Phase
- Phase 2
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. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites
Kyungpook National University Chilgok Hospital
Daegu, Daegu
Study Coordinator
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do
Study Coordinator
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Study Coordinator
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, Seoul, 03312
Study Coordinator
Chung-Ang University Hospital
Seoul, Seoul
Study Coordinator
Ewha Womans University Seoul Hospital
Seoul, Seoul
Study Coordinator
Yongin Severance Hospital, Yonsei University Health System
Yongin, Gyeonggi-do
Study Coordinator
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 startApr 2026 (estimated)
- 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
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided