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NCT06162494

Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Enrolling by Invitation
PHASE4Ages 19–40InterventionalPrevention
Ann & Robert H Lurie Children's Hospital of Chicago
~80 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Recombinant Zoster Vaccine

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Event Reporting
Measured over 30 days-1 year
+1 more outcome measured

Conditions

Varicella Zoster

Explore related trials

Solid organ transplant to recipientVaricella Zoster

Where it's being run

3 sites across 2 states
Illinois2
Ohio1

Study leadership

  • Ravi Jhaveri, MD · PRINCIPAL_INVESTIGATOR · Ann and Robert H Lurie Children's Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse Event Reporting30 days-1 year

    Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories 1. Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2) 2. Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2) 3. Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2) 4. Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study

  • Anti-glycoprotein E antibody Concentration30-60 days

    Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration