Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50… (NCT06137755) | Clinical Trial Compass
RecruitingPhase 1
Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
South Korea32 participantsStarted 2023-03-15
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
Who can participate
Age range
50 Years – 64 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
. 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.
Exclusion criteria
. 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
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
Immediate adverse events
Timeframe: within 30 minutes at each vaccination timepoint
2
Solicited local and systemic signs and symptoms
Timeframe: Day 0 - Day 6 for each vaccination timepoint
3
Unsolicited signs and symptoms
Timeframe: Until Week 4 post the 2nd vaccination
4
SAEs
Timeframe: Until Week 48 post the 2nd vaccination
5
MAAEs
Timeframe: Until Week 48 post the 2nd vaccination
6
AESIs
Timeframe: Until Week 48 post the 2nd vaccination
7
Safety as measured by clinical laboratory test, vial sign and physical examination parameters
. 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)