Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Enrolling by invitation · Phase 4

Conditions studied: Varicella Zoster

In brief

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.

Key facts

Study ID

NCT06162494

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

80

Starts

2024-03-18

Expected to finish

2028-09-30

Last updated by the study team

2026-03-27

Who can join

Age: 19 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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