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

NCT02692066 | Withdrawn

• 1 other identifier: 15-2042
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 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. 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

Outcome Measures

Primary Outcomes (3)

• clearance of viral DNA

  4 weeks

• humoral response

  4 weeks

• cell mediated response

  4 weeks

Study Arms (2)

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

Biological: varicella vaccine

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

Biological: varicella vaccine

Interventions

varicella vaccine BIOLOGICAL

Children with Chronic Liver Disease; Healthy Controls

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with liver disease and healthy controls who have not received varicella vaccination and who have no history of varicella or zoster

You may qualify if:

• months to 21 years
• no history of varicella, zoster or prior varicella vaccination

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Amy Feldman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 25, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 9, 2018

Record last verified: 2018-05