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Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.

Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02692066
Enrollment
0
Registered
2016-02-25
Start date
2016-04-30
Completion date
2016-04-30
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella, Transplants

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.

Interventions

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
Yes

Inclusion criteria

* 6 months to 21 years * no history of varicella, zoster or prior varicella vaccination

Exclusion criteria

* acute liver failure * liver transplant anticipated within 28 days * prior history of receiving blood products or immunoglobulin within 5 months prior to vaccination * fever * pregnancy * immunocompromised status * receiving immunosuppressive meds

Design outcomes

Primary

MeasureTime frame
clearance of viral DNA4 weeks
humoral response4 weeks
cell mediated response4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026