Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00614640
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2008-02-11
Brief Title:
Safety and Tolerability of a Therapeutic DNA Dendritic Cell Vaccine in HIV-Infected Children Adolescents and Young Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of the Safety Tolerability and Immunogenicity of a Topical Therapeutic DNA Dendritic Cell Vaccine DermaVir Patch in Children Adolescents and Young Adults With HIV-1 Infection on Highly Active Antiretroviral Therapy HAART
Status:
WITHDRAWN
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 therapeutic DNA vaccine DermaVir represents an immunization strategy that targets lymph node dendritic cells Because of the high percentage of naive CD4 cells in children and adolescents the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults
Detailed Description:
The introduction of highly active antiretroviral therapy HAART for children and adolescents has resulted in improved control of viral replication for prolonged periods of time and a significant reduction in morbidity However when compared to the responses seen in adults children have overall inferior virologic responses The therapeutic vaccine DermaVir represents an immunization strategy that targets lymph node dendritic cells Because of the high percentage of naive CD4 cells in children and adolescents the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults
This study will last up to 61 weeks up to 13 weeks of treatment with an additional 48 weeks for follow-up Participants will be randomly stratified according to age and dosage Group 1 will consist of 8 adolescents and young adults between ages 13 and 23 and 8 children between ages 6 and 12 Group 1 participants will have one 08 ml DermaVir patch and one control patch applied on Days 0 42 and 84 Group 2 will consist of 4 adolescents and young adults and 4 children Group 2 participants will have four 08 ml DermaVir patches applied on Days 0 42 and 84 Group 3 will consist of 4 adolescents and young adults and 4 children Group 3 participants will have four 08 ml DermaVir patches applied on Days 0 7 42 49 84 and 91
There will be 14 study visits for each participant They will occur at screening and Days 0 7 21 42 49 63 84 91 105 126 168 259 and 427 Screening will occur up to 30 days before the first vaccination Day 0 Medical history and physical exam will occur at all visits Blood and urine collection and an adherence assessment will occur at most visits A urine pregnancy test will occur for females at most visits
This study will last up to 61 weeks up to 13 weeks of treatment with an additional 48 weeks for follow-up Participants will be randomly stratified according to age and dosage Group 1 will consist of 8 adolescents and young adults between ages 13 and 23 and 8 children between ages 6 and 12 Group 1 participants will have one 08 ml DermaVir patch and one control patch applied on Days 0 42 and 84 Group 2 will consist of 4 adolescents and young adults and 4 children Group 2 participants will have four 08 ml DermaVir patches applied on Days 0 42 and 84 Group 3 will consist of 4 adolescents and young adults and 4 children Group 3 participants will have four 08 ml DermaVir patches applied on Days 0 7 42 49 84 and 91
There will be 14 study visits for each participant They will occur at screening and Days 0 7 21 42 49 63 84 91 105 126 168 259 and 427 Screening will occur up to 30 days before the first vaccination Day 0 Medical history and physical exam will occur at all visits Blood and urine collection and an adherence assessment will occur at most visits A urine pregnancy test will occur for females at most visits
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 |
|---|---|---|---|
| IMPAACT P1049 | Registry Identifier | DAIDS ES Registry Number | None |
| 10165 | REGISTRY | None | None |