Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775718
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-02-28
Brief Title:
Shingrix In Recipients of Allogeneic Transplants
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Safety and Immunogenicity of Shingrix Administered to Recipients of Allogeneic Peripheral and Cord Blood Stem Cell Transplants Effect of Timing of Vaccination After Transplantation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Allo
Brief Summary:
This research is designed to determine if the adjuvanted recombinant glycoprotein E gE herpes zoster HZ vaccine Shingrix has acceptable immunogenicity and safety in people who have undergone allogeneic stem cell transplant allo-SCT Specifically it will determine the effect of the interval after transplantation on the immune response and if an additional dose of vaccine is needed to improve the vaccine-induced responses
Detailed Description:
This is a phase II single center prospective unblinded immunogenicity and safety study It is anticipated that enrollment will take approximately 6 months Duration of participation for study subjects is approximately 1 year During this interval participants will continue to receive clinical care from the BMT center which will ensure retention
Participants will be recruited at their routine clinic visits which take place every 6 months post-transplantation or will be recruited by phone Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr Levins Vaccine Research Clinic where they will also receive the 3rd dose of vaccine
Participants will be recruited at their routine clinic visits which take place every 6 months post-transplantation or will be recruited by phone Participants will be consented by study personnel in coordination with the BMT health care providers and subsequently followed in Dr Levins Vaccine Research Clinic where they will also receive the 3rd dose of vaccine
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?:
None
Is an FDA AA801 Violation?:
None