Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005009
Status:
TERMINATED
Last Update Posted:
2017-02-16
First Post:
2000-03-28
Brief Title:
Evaluation of the Safety of Varivax in Pediatric Renal Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Safety and Immunogenicity of Varivax Live-Attenuated Varicella-Zoster Virus Vaccine in Pediatric Renal Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Pediatric renal transplant patients face a lifetime of immunosuppressive therapy that place 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 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 aims to quantify the safety and immunogenicity of Varivax in the population of pediatric renal transplant patients least susceptible to VZV infection ie those on minimal maintenance immunosuppression and at least 1 year out 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
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 aims to quantify the safety and immunogenicity of Varivax in the population of pediatric renal transplant patients least susceptible to VZV infection ie those on minimal maintenance immunosuppression and at least 1 year out 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None