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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02692066
• Other study ID #: 15-2042
• Status: Withdrawn
• Start date: April 2016
• Est. completion date: April 2016

Study information

• Verified date: May 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Transplants
• Varicella

Intervention

Biological:
• varicella vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance of viral DNA		4 weeks
Primary	humoral response		4 weeks
Primary	cell mediated response		4 weeks