Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-29 @ 10:14 AM
Study NCT ID:
NCT02692066
Status:
WITHDRAWN
Last Update Posted:
2018-05-09
First Post:
2016-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding not acquired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Varicella zoster virus (VZV) can lead to significant morbidity and mortality in transplant recipients. Current recommendations suggest a 4 week waiting period between vaccination and transplantation and consideration of booster immunizations if antibody response does not reach target levels. This four week waiting period can result in delayed transplant, rejection of an optimal organ, or missed opportunity to vaccinate. However, these recommendations are not evidence based.
This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.
Investigators will evaluate:
1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.
This is a prospective study to look at the immune response to varicella vaccine in children with chronic liver disease.
Investigators will evaluate:
1. the time at which VZV DNA becomes undetectable in blood and saliva by PCR after vaccination in children with chronic liver disease and
2. the difference in humoral and cell mediated immune response to varicella immunization between children with chronic liver disease and healthy children.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: