Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06162494
Eligibility Criteria:
Inclusion Criteria:
* 19 years of age or older and willing to provide written informed consent for the study participation.
* Prior recipient of solid organ transplant more than one year prior to participation.
* Stable immunosuppressive medication regimen for last 6 months prior to participation
* Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
* For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.
Exclusion Criteria:
* Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
* More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
* History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
* Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
* History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
* Active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine
* Febrile illness with Temp ≥39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1.
* Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
40 Years
Study:
NCT06162494
Study Brief:
Protocol Section:
NCT06162494