Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000837
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine Varivax in HIV-Infected Children
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 it is safe to give Varivax to HIV-positive children and whether it protects children from infection Varivax is a vaccine against varicella zoster virus VZV the virus that causes chickenpox varicella and shingles zoster
VZV can cause many serious complications in HIV-infected children Varivax is a VZV vaccine that has been approved for use in healthy children More research is needed to find out how this vaccine will affect HIV-infected children
VZV can cause many serious complications in HIV-infected children Varivax is a VZV vaccine that has been approved for use in healthy children More research is needed to find out how this vaccine will affect HIV-infected children
Detailed Description:
Primary varicella infection or chickenpox can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the childs lifetime and timely notification of exposure is not always possible Since Varivax has been licensed for routine vaccination of healthy individuals it must be determined whether this vaccine can be safely administered to HIV-infected children
Thirty-six children who are varicella zoster virus VZV-naive treatment group receive Varivax at Weeks 0 and 12 with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection Twenty children who have a history of wild-type varicella exposure within the past year control group receive no study treatment All patients are either asymptomatic or mildly symptomatic for HIV infection Patients make 12-14 visits to the clinic AS PER AMENDMENT 9999 This study has been reorganized into two cohorts asymptomatic and symptomatic In the asymptomatic cohort accrual has been completed with 40 patients in Treatment Group I and 19 in the control group This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease The symptomatic cohort includes Treatment Groups II and III each with 30 patients The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles the remaining 20 Group II and the first 10 Group III patients are enrolled The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients
Thirty-six children who are varicella zoster virus VZV-naive treatment group receive Varivax at Weeks 0 and 12 with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection Twenty children who have a history of wild-type varicella exposure within the past year control group receive no study treatment All patients are either asymptomatic or mildly symptomatic for HIV infection Patients make 12-14 visits to the clinic AS PER AMENDMENT 9999 This study has been reorganized into two cohorts asymptomatic and symptomatic In the asymptomatic cohort accrual has been completed with 40 patients in Treatment Group I and 19 in the control group This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease The symptomatic cohort includes Treatment Groups II and III each with 30 patients The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles the remaining 20 Group II and the first 10 Group III patients are enrolled The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients
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 265 | Registry Identifier | DAIDS ES Registry Number | None |
| 10613 | REGISTRY | None | None |