Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001125
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-01-17
Brief Title:
Use of a Varicella-Zoster Virus VZV Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Use of a Live-Attenuated Varicella-Zoster Virus VZV Vaccine to Boost Immunity to VZV in HIV-Infected Children Previously Infected With Varicella
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 see if the varicella-zoster virus VZV vaccine will be safe and if it can help prevent shingles in HIV-infected children who have already had chickenpox
VZV is the virus that causes chickenpox If this virus is reactivated in the body it can also cause shingles Shingles is common in children with HIV who have had chickenpox although it is usually not life-threatening The VZV vaccine used in this study may be able to prevent HIV-positive children who have had chickenpox from developing shingles
VZV is the virus that causes chickenpox If this virus is reactivated in the body it can also cause shingles Shingles is common in children with HIV who have had chickenpox although it is usually not life-threatening The VZV vaccine used in this study may be able to prevent HIV-positive children who have had chickenpox from developing shingles
Detailed Description:
Varicella chickenpox results from primary infection with VZV Varicella a common and usually benign illness in normal children is more severe in HIV-infected children and may result in other conditions such as HZ shingles HZ is due to reactivation of latent VZV acquired during varicella and is common in HIV-infected children who have had natural varicella While HZ is not likely to be life-threatening in these children it does cause considerable morbidity and interferes with quality of life Use of a live-attenuated VZV vaccine may be able to boost immunity in these children
Two immunologic cohorts are enrolled Cohort A includes children with a CD4 cell percentage greater than or equal to 20 percent that has been documented as stable for at least the 6 months prior to the time varicella developed confirmed by a minimum of 2 tests and a CD4 cell percentage greater than AS PER AMENDMENT 102799 or equal to 15 percent that has been documented as stable for at least the 6 months prior to enrollment confirmed by a minimum of 2 tests Cohort B includes children with a CD4 cell percentage greater than or equal to 10 percent and less than 15 percent that has been documented as stable for at least the 6 months prior to the time varicella developed and stable for at least the 6 months prior to enrollment confirmed by a minimum of 2 tests AS PER AMENDMENT 42001 Cohort B includes children who have a CD4 cell percentage less than 15 documented by a minimum of 1 but preferably 2 tests within 1 year of onset of varicella ie within 1 year before to 1 year after varicella and a CD4 cell percentage greater than or equal to 15 documented by a minimum of 2 tests at the time of enrollment A pilot study precedes the full study AS PER AMENDMENT 102799 The pilot study for Cohort A precedes the full study for Cohort A and the pilot study for Cohort B The pilot study for Cohort B precedes the full study for Cohort B The pilot study includes 10 children from each cohort who receive live-attenuated VZV at Weeks 0 and 8 If 3 pilot-study patients in a cohort meet a toxicity endpoint related to the vaccine the dose regimen has failed the safety criteria for that cohort AS PER AMENDMENT 102799 If 3 children in the pilot study for Cohort A meet a toxicity endpoint deemed to be related to the vaccine the dose regimen has failed safety criteria for both cohorts If 3 children in the pilot phase of Cohort B meet a toxicity endpoint deemed related to the vaccine the dose regimen has failed the safety criteria for Cohort B If at 12 weeks after immunization at least 5 pilot-study patients in a cohort respond and the safety profile is deemed adequate the pilot study extends into a full study with the immunization of an additional 20 patients from that cohort AS PER AMENDMENT 102799 If at Week 12 at least 5 pilot-study patients in Cohort A meet immunologic criteria and the safety profile is deemed adequate then the full study for Cohort A and the pilot study for Cohort B opens If the same immunologic and safety criteria are met for the pilot study for Cohort B then the full study for Cohort B opens If either cohort shows an inadequate immunologic response or safety profile the study team reviews the results to determine if another regimen should be considered In the full study patients receive 2 immunizations at Weeks 0 and 8 Varicella antibody titers and in vitro responder cell frequency RCF assays are measured at Weeks 0 4 8 12 24 52 78 and 104 Symptoms HIV progression and VZV presence are monitored throughout the study
Two immunologic cohorts are enrolled Cohort A includes children with a CD4 cell percentage greater than or equal to 20 percent that has been documented as stable for at least the 6 months prior to the time varicella developed confirmed by a minimum of 2 tests and a CD4 cell percentage greater than AS PER AMENDMENT 102799 or equal to 15 percent that has been documented as stable for at least the 6 months prior to enrollment confirmed by a minimum of 2 tests Cohort B includes children with a CD4 cell percentage greater than or equal to 10 percent and less than 15 percent that has been documented as stable for at least the 6 months prior to the time varicella developed and stable for at least the 6 months prior to enrollment confirmed by a minimum of 2 tests AS PER AMENDMENT 42001 Cohort B includes children who have a CD4 cell percentage less than 15 documented by a minimum of 1 but preferably 2 tests within 1 year of onset of varicella ie within 1 year before to 1 year after varicella and a CD4 cell percentage greater than or equal to 15 documented by a minimum of 2 tests at the time of enrollment A pilot study precedes the full study AS PER AMENDMENT 102799 The pilot study for Cohort A precedes the full study for Cohort A and the pilot study for Cohort B The pilot study for Cohort B precedes the full study for Cohort B The pilot study includes 10 children from each cohort who receive live-attenuated VZV at Weeks 0 and 8 If 3 pilot-study patients in a cohort meet a toxicity endpoint related to the vaccine the dose regimen has failed the safety criteria for that cohort AS PER AMENDMENT 102799 If 3 children in the pilot study for Cohort A meet a toxicity endpoint deemed to be related to the vaccine the dose regimen has failed safety criteria for both cohorts If 3 children in the pilot phase of Cohort B meet a toxicity endpoint deemed related to the vaccine the dose regimen has failed the safety criteria for Cohort B If at 12 weeks after immunization at least 5 pilot-study patients in a cohort respond and the safety profile is deemed adequate the pilot study extends into a full study with the immunization of an additional 20 patients from that cohort AS PER AMENDMENT 102799 If at Week 12 at least 5 pilot-study patients in Cohort A meet immunologic criteria and the safety profile is deemed adequate then the full study for Cohort A and the pilot study for Cohort B opens If the same immunologic and safety criteria are met for the pilot study for Cohort B then the full study for Cohort B opens If either cohort shows an inadequate immunologic response or safety profile the study team reviews the results to determine if another regimen should be considered In the full study patients receive 2 immunizations at Weeks 0 and 8 Varicella antibody titers and in vitro responder cell frequency RCF assays are measured at Weeks 0 4 8 12 24 52 78 and 104 Symptoms HIV progression and VZV presence are monitored throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG 391 | Registry Identifier | DAIDS ES Registry Number | None |
| 10614 | REGISTRY | None | None |