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

NCT ID: NCT02692066

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Varicella; Transplants

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Controls

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

varicella vaccine

Intervention Type: BIOLOGICAL

Children with Chronic Liver Disease

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

varicella vaccine

Intervention Type: BIOLOGICAL

Interventions

varicella vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

15-2042

Identifier Type: -

Identifier Source: org_study_id