Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients
Stopped early · Phase 1
Conditions studied: Kidney Transplant Recipients
In brief
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 chickenpox (varicella) and shingles (zoster). Healthy children are already receiving Varivax shots to protect them from chickenpox. 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 ultimately want to learn whether Varivax might safely prevent VZV infections in children who have had kidney transplants.
Key facts
- Study ID
- NCT00005009
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 7
- Starts
- 1998-02-01
- Expected to finish
- 2001-06-16
- Last updated by the study team
- 2017-02-16
Who can join
Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Your child may be eligible for this trial if he/she:
- Had a kidney transplant 1 year ago or more;
- Is between 2 and 21 years of age (parent or guardian's signed informed consent required if under 18);
- Is taking stable, maintenance doses of immunosuppressive drugs for his/her kidney transplant; and
- Is generally in good health.
You may not qualify if…
- 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 their 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 pager; or
- Has had blood or plasma transfusions or taken certain drugs in the last 6 months.
Where it is running
- University of Alabama at Birmingham - Vaccine and Treatment Evaluation Unit (VTEU) — Birmingham, Alabama, United States
- Boston Children's Hospital - Vaccine and Treatment Evaluation Unit (VTEU) — Boston, Massachusetts, United States
- University of Michigan - Vaccine and Treatment Evaluation Unit (VTEU) — Ann Arbor, Michigan, United States
- University of Texas Health Science Center at San Antonio - Vaccine and Treatment Evaluation Unit (VTEU) — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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