Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients (NCT00005009) | Clinical Trial Compass
TerminatedPhase 1
Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients
Stopped: Slow enrollment
United States7 participantsStarted 1998-02
Plain-language summary
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.
Who can participate
Age range
2 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immediate adverse reactions
Timeframe: 30 minutes post vaccination
2
Varicella related adverse reactions
Timeframe: 1 year
3
Rejection events
Timeframe: 1 year
Trial details
NCT IDNCT00005009
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)