Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine.
- Conditions
- VaricellaTransplants
- Registration Number
- NCT02692066
- Lead Sponsor
- University of Colorado, Denver
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 6 months to 21 years
- no history of varicella, zoster or prior varicella vaccination
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clearance of viral DNA 4 weeks humoral response 4 weeks cell mediated response 4 weeks
- Secondary Outcome Measures
Name Time Method