Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

NCT06162494 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 2022-5099
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Varicella Zoster

Keywords

Solid Organ Transplant; Vaccine

Outcome Measures

Primary Outcomes (2)

• Adverse Event Reporting

  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

  30 days-1 year

• Anti-glycoprotein E antibody Concentration

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

  30-60 days

Secondary Outcomes (2)

• Glycoprotein E-Specific Cellular Responses

  30-60 days

• Acute Rejection Reporting

  2 months

Other Outcomes (1)

• Exploratory Outcome

  30-60 days

Study Arms (1)

Recombinant Zoster Vaccine Administration and Testing

EXPERIMENTAL

all participants will receive 2 doses of recombinant zoster vaccine (Shingrix)

Biological: Recombinant Zoster Vaccine

Interventions

Recombinant Zoster Vaccine BIOLOGICAL

After giving consent, participants will be given first dose of vaccine. Participants will be brought back 60-90 days post-vaccine for follow up testing and second dose of vaccine

Also known as: Shingrix

Recombinant Zoster Vaccine Administration and Testing

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Children's Hospital Colorado: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (3)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Ravi Jhaveri, MD

  Ann and Robert H Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head of Pediatric Infectious Diseases, Principal Investigator

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 8, 2023
• Study Start: March 18, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)