Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

Launched by ANN & ROBERT H LURIE CHILDREN'S HOSPITAL OF CHICAGO · Nov 27, 2023

Keywords

ClinConnect Summary

This study is testing whether the recombinant zoster vaccine (Shingrix) is safe and can create a strong immune response to prevent shingles in young adults who have received a solid organ transplant (like heart, liver, or kidney). It is a single-group, open-label trial (everyone knows what they’re getting) and uses a two-dose vaccine series given a few months apart. Researchers will look at safety events over about a year and also measure how well the vaccine stimulates antibodies and immune cells.

People eligible to participate are adults aged 19 to 40 who had a solid organ transplant more than one year ago and have been on a stable immunosuppressive medicine plan for the past six months. They should be willing to be contacted for follow-up and must not have recent shingles or certain recent vaccinations around dosing. If enrolled, participants receive the first vaccine dose, return 60–90 days later for the second dose, and then come back for follow-up testing over the next 12–15 months to watch for side effects and signs of organ rejection, while checking antibody and cellular immune responses. The study is currently enrolling by invitation at Ann & Robert H. Lurie Children’s Hospital in Chicago, aims to enroll about 80 people, and results aren’t available yet; the study is planned to finish around 2028.

Gender

ALL

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