An observational study in Varicella and Transplants, sponsored by University of Colorado, Denver. Withdrawn. Open to participants aged 6 Months to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by University of Colorado, Denver · Observational
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:
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Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster
Exclusion Criteria:
Healthy Children ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) markers of humoral immunity at baseline and 4 weeks post vaccination and 2) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination
Biological: varicella vaccine
Children with chronic liver disease ages 6 months-21 years who have not received varicella vaccine and who do not have prior varicella or zoster will receive Varivax. We will then measure 1) varicella DNA in the blood and saliva at enrollment, 1 week, 2 weeks, 3 weeks, 4 weeks post vaccination 2)markers of humoral immunity at baseline and 4 weeks post vaccination and 3) markers of cell mediated immunity at baseline, 1 week, and 4 weeks post vaccination
Biological: varicella vaccine
clearance of viral DNA
Time frame: 4 weeks
humoral response
Time frame: 4 weeks
cell mediated response
Time frame: 4 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver