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Prevention study for Vaccine-Preventable Diseases
Official title Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
ClinicalTrials.gov ID: NCT06137755
What this study is testing
What is CVI-VZV-001?
CVI-VZV-001 is an investigational medicine, being studied as a potential treatment for vaccine-preventable diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Women of childbearing potential with negative result at pregnancy test before vaccination for clinical trials.
You likely can't join if
- 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\...
- 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...
- Those with a history of excessive alcohol consumption or drug addiction
See the full eligibility criteria
- 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...
- Women of childbearing potential with negative result at pregnancy test before vaccination for clinical trials.
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Eunpyeong-gu, South Korea
- Seongnam-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Eunpyeong-gu, South Korea; Seongnam-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.