A Study of the Safety and Effectiveness of Varivax (the Chicken Pox Vaccine) in Children Who Have Received Kidney Transplants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00005009
First received: March 28, 2000
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to find out whether Varivax is safe for use in children with kidney transplants and whether it protects children from serious infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chicken pox (varicella) and shingles (zoster).

Healthy children are already receiving Varivax shots to protect them from chicken pox. Few children with kidney transplants have received Varivax because doctors have been concerned that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a life-threatening disease in these children. For this reason, doctors want to learn whether Varivax might safely prevent VZV infections in children who have had kidney transplants.


Condition Intervention Phase
Chickenpox
Kidney Transplantation
Varicella Zoster
Biological: Varicella Virus Vaccine Live
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Immunogenicity of Varivax (Live-Attenuated Varicella-Zoster Virus Vaccine) in Pediatric Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Immediate adverse reactions [ Time Frame: 30 minutes post vaccination ] [ Designated as safety issue: Yes ]
  • Varicella related adverse reactions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1. Fever and local (<1 inch from inoculation site) lesions
    2. Fever and lesions outside the 1 inch inoculation site
    3. Lesions outside the 1 inch inoculation site
    4. Clinical signs of pneumonitis
    5. Clinical or chemical signs of hepatitis
    6. Development of thrombocytopenia

  • Rejection events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1. Increase in creatinine
    2. Renal biopsy


Estimated Enrollment: 50
Study Start Date: February 1998
Study Completion Date: June 2001
Detailed Description:

Pediatric renal transplant patients face a lifetime of immunosuppressive therapy that places them at high risk for potentially life-threatening infection by primary varicella-zoster virus (VZV). Treatment for acute episodes of VZV infection is possible but expensive and provides no long-term protection from VZV. Furthermore, therapy to overcome VZV infections can lead to renal graft rejection. Varivax has proven safe, immunogenic, and effective in the normal host and has been recommended for universal administration in the general population at age 12 months. It is not currently labeled for use in immunocompromised patients. However, recent studies in pediatric leukemia and pediatric renal transplant patients suggest that attenuated live vaccine can confer protection with minimal adverse events even in the presence of immunosuppression, providing encouragement for more careful studies of VZV immunization in renal transplant patients. This study endeavors to quantify the immunogenicity and safety of Varivax in the population of pediatric renal transplant patients least susceptible to VZV infection, i.e., those on minimal maintenance immunosuppression and at least 1 year from transplant.

Patient enrollment is staged to allow study physicians to closely monitor patients for signs of disseminated varicella reactions or graft rejection. Initially only 1 patient will be enrolled in the study. If the first patient reaches Week 8 without a severe adverse reaction, 3 study centers will then enroll 3 additional patients. If 8 weeks later these 3 patients have had no severe adverse reactions, the same 3 study centers will enroll 3 more patients. At the end of this period, having ascertained the safety of the vaccine in the first 7 patients, the study will be opened to the remaining centers. Patients receive 2 doses of Varivax 6 to 8 weeks apart. Each week for 6 to 8 weeks after the first vaccine dose, the patient undergoes venipuncture and clinical assessment to characterize renal graft and liver function and identify any signs of varicella infection. Additional telephone follow-up occurs on Day 4 and twice weekly thereafter. Parents or guardians monitor the patient for evidence of rash or fever and immediately report any rashes or fevers to study physicians. If, after 6 to 8 weeks, the patient demonstrates no severe reactions to the vaccine and requires no antiviral therapy, the patient receives the second vaccine dose. The patient again receives weekly on-site and telephone follow-up for 6 weeks. Other visits occur 9 weeks and 14 weeks after the second vaccine dose and 1 year after the first vaccine dose. At these visits the patient undergoes venipuncture and clinical assessment to identify potential rejection events or varicella infection and to characterize VZV antibody responses and cytokine changes in response to the vaccine.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Your child may be eligible for this trial if he/she:

  • Had a kidney transplant 1 year ago or more.
  • Is between ages 2 and 21 (parent or guardian's signed informed consent required if under 18).
  • Is taking stable, maintenance doses of immunosuppressive drugs for his/her kidney transplant.
  • Is generally in good health.

Exclusion Criteria

Your child will not be eligible for this trial if he/she:

  • Has had any rejection episodes in the last 6 months or has other problems with his/her kidneys.
  • Was in the hospital for a major infection in the last 30 days.
  • Has a history of VZV infection, including chicken pox or shingles.
  • Has ever received a VZV vaccine, including Varivax.
  • Lives with a person whose immune system does not work well.
  • Is allergic to certain medications.
  • Is unable to return for the prescribed follow-up check-ups.
  • Has no phone or beeper.
  • Has had blood or plasma transfusions or taken certain drugs in the last 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005009

Locations
United States, Maryland
Ann Limberger
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00005009     History of Changes
Other Study ID Numbers: DAIT VZV
Study First Received: March 28, 2000
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014