Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026624
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-11-12
Brief Title:
SafetyImmunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
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 to Evaluate the Safety and Immunogenicity of the Subcutaneous Administration of ALVAC-HIV vCP1452 Infected Autologous Dendritic Cells Versus the Subcutaneous Administration of ALVAC-HIV vCP1452 To HIV-Infected Subjects
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 determine how safe it is to give patients a shot that has a mixture of a vaccine and dendritic cells DCs a special kind of immune cell and how safe it is to give a shot of the vaccine alone
Current HIV vaccines have not been strong enough to give good immune responses Research has shown that the immune response to a vaccine delivered by DCs is greater than the response without DC delivery A5130 is a study that seeks to give good delivery of the vaccine to important immune cells of the body
Current HIV vaccines have not been strong enough to give good immune responses Research has shown that the immune response to a vaccine delivered by DCs is greater than the response without DC delivery A5130 is a study that seeks to give good delivery of the vaccine to important immune cells of the body
Detailed Description:
Cytotoxic T-cell lymphocyte CTL responses are important in viral destruction and thereby in the protective immune response to viral infection Current HIV vaccines do not consistently elicit strong CTL responses The limited immune response of current HIV vaccines could be attributed in addition to other causes to failure of the vaccine to reach the appropriate cells to initiate a robust immune response DCs particularly are effective in stimulating primary T-cell-dependent immunity Antigen-bearing DCs are used as adjuvants for active immunotherapy in humans particularly to increase host resistance to tumors and certain viral infections A5130 is an exploratory proof-of-concept study that seeks to ensure adequate delivery of the vaccine to important antigen-presenting cells
Patients are randomized into 1 of 2 vaccination groups at entry Group A Patients receive an SC vaccination with DCs infected with ALVAC-HIV vCP1452 DC exposure to KLH occurs at Weeks 3 and 7 Leukopheresis occurs at entry
Group B Patients receive an SC vaccination with ALVAC-HIV vCP1452 without DCs KLH injections are administered at Weeks 3 and 7
Patients in both groups receive their vaccinations at Weeks 3 7 and 15 This study consists of 4 steps but not all patients necessarily qualify to enter Step II Step III or Step IV
Step I vaccination phase Step II withdrawal of potent ART Step III optional discontinuation of ART Step IV reinitiation of ART AS PER AMENDMENT 041002 Step V follow-up period off potent ART
Patients are randomized into 1 of 2 vaccination groups at entry Group A Patients receive an SC vaccination with DCs infected with ALVAC-HIV vCP1452 DC exposure to KLH occurs at Weeks 3 and 7 Leukopheresis occurs at entry
Group B Patients receive an SC vaccination with ALVAC-HIV vCP1452 without DCs KLH injections are administered at Weeks 3 and 7
Patients in both groups receive their vaccinations at Weeks 3 7 and 15 This study consists of 4 steps but not all patients necessarily qualify to enter Step II Step III or Step IV
Step I vaccination phase Step II withdrawal of potent ART Step III optional discontinuation of ART Step IV reinitiation of ART AS PER AMENDMENT 041002 Step V follow-up period off potent ART
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 A5130 | Registry Identifier | DAIDS ES Registry Number | None |
| AACTG A5130 | None | None | None |
| 10080 | REGISTRY | None | None |