Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients (NCT06162494) | Clinical Trial Compass
By InvitationPhase 4
Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
United States80 participantsStarted 2024-03-18
Plain-language summary
This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
Who can participate
Age range
19 Years – 40 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:
* 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 1…
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
Adverse Event Reporting
Timeframe: 30 days-1 year
2
Anti-glycoprotein E antibody Concentration
Timeframe: 30-60 days
Trial details
NCT IDNCT06162494
SponsorAnn & Robert H Lurie Children's Hospital of Chicago