Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above (NCT07481604) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
South Korea135 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody
Timeframe: Baseline to 4 weeks after the second vaccination