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

Withdrawn

• Conditions: Varicella; Transplants
• Interventions: Biological: varicella vaccine

• 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

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-25
• Study Start: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with Chronic Liver Disease	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
Healthy Controls	varicella vaccine	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

Primary Outcome Measures

Name	Time	Method
cell mediated response	4 weeks
clearance of viral DNA	4 weeks
humoral response	4 weeks