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.
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
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Mar 2023to 21 Mar 2025
- Phase
- Phase 1
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. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Bundang CHA General Hospital
Seongnam-si, Gyeonggi-do, 13496
Jonghoon Kim
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312
Jeonghyeon Choi
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
- Conditions
- Vaccine-Preventable Diseases, Herpes Zoster
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Recombinant 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 2 | Experimental | Recombinant 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 3 | Experimental | Recombinant 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 Control | Active comparator | Shingrix 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.
Immediate adverse events
Occurrence of immediate adverse events
Measured: within 30 minutes at each vaccination timepoint
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
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
SAEs
Occurrence of serious adverse events (SAEs)
Measured: Until Week 48 post the 2nd vaccination
MAAEs
Occurrence of Medically attended adverse events(MAAEs)
Measured: Until Week 48 post the 2nd vaccination
AESIs
Occurrence of adverse events (AEs) of special interest
Measured: Until Week 48 post the 2nd vaccination
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)
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
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.
- First posted18 Nov 2023
- Study start15 Mar 2023
- Primary completion21 Mar 2025 (estimated)
- Study completion21 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aribio Lab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeonghyeon Choi, Principal investigator, The Catholic University of Korea Eunpyeong St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137755
- Sponsor's protocol ID
- CVI-VZV-001-CT2101
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No