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

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ClinicalTrials.gov Identifier: NCT02692066
Recruitment Status : Withdrawn (Funding not acquired)
First Posted : February 25, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment
Varicella Transplants Biological: varicella vaccine

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Response and Clearance of Viral DNA Following Administration of Live Attenuated Varicella Vaccine in Children With Liver Disease
Estimated Study Start Date : April 2016
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. clearance of viral DNA [ Time Frame: 4 weeks ]
  2. humoral response [ Time Frame: 4 weeks ]
  3. cell mediated response [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692066


Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Amy Feldman, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02692066    
Other Study ID Numbers: 15-2042
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
 DNA Virus Infections
Virus Diseases
Infections