Study Stopped
Slow enrollment
Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients
Evaluation of the Safety and Immunogenicity of Varivax® (Live-Attenuated Varicella-Zoster Virus Vaccine) in Pediatric Renal Transplant Recipients
1 other identifier
interventional
7
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 1998
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1998
CompletedFirst Submitted
Initial submission to the registry
March 28, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 16, 2017
February 1, 2017
3.4 years
March 28, 2000
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Immediate adverse reactions
30 minutes post vaccination
Varicella related adverse reactions
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
1 year
Rejection events
1. Increase in creatinine 2. Renal biopsy
1 year
Study Arms (1)
Varivax®
EXPERIMENTAL0.5 mL of Varivax administered subcutaneously in the right upper arm (deltoid region).
Interventions
Each participant will receive 2 doses of Varivax 6 to 8 weeks apart.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Merck Sharp & Dohme LLCcollaborator
- Cooperative Clinical Trials in Pediatric Transplantationcollaborator
- North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS)collaborator
- NIAID Vaccine and Treatment Evaluation Units (VTEUs)collaborator
Study Sites (4)
University of Alabama at Birmingham - Vaccine and Treatment Evaluation Unit (VTEU)
Birmingham, Alabama, 35401, United States
Boston Children's Hospital - Vaccine and Treatment Evaluation Unit (VTEU)
Boston, Massachusetts, 02115, United States
University of Michigan - Vaccine and Treatment Evaluation Unit (VTEU)
Ann Arbor, Michigan, 48103, United States
University of Texas Health Science Center at San Antonio - Vaccine and Treatment Evaluation Unit (VTEU)
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amir Tejani, MD
North American Pediatric Renal Transplantation Study (NAPRTCS)
- STUDY CHAIR
Beverly L. Connelly, MD
Vaccine and Treatment Evaluation Unit (VTEU)-Cincinnati Children's
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2000
First Posted
August 31, 2001
Study Start
February 1, 1998
Primary Completion
June 16, 2001
Study Completion
June 16, 2001
Last Updated
February 16, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.