NCT06162494

Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.

Conditions

• Varicella Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine	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

Timeline

• Start date: 2024-03-18
• Primary completion: 2027-03-31
• Completion: 2028-09-30
• First posted: 2023-12-08
• Last updated: 2026-03-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study