Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-27
Brief Title:
Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None