Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013572
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-03-21
Brief Title:
HIV Candidate Vaccine ALVAC-HIV-1 Administration in HIV-Negative Adults
Sponsor:
Walter Reed Army Institute of Research WRAIR
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV vCP205 HIV-1 EnvGagPol in Seronegative Adults Administered 1 Subcutaneously Via Ex Vivo Transfected Autologous Dendritic Cells 2 Intradermally or 3 Intramuscularly
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 the best way to administer the candidate HIV vaccine ALVAC HIV-1 vCP205
Detailed Description:
Healthy adult volunteers are assigned randomly to either a vaccine or placebo group Injections are received either intramuscularly intradermally or by delivery under the skin of the volunteers own white blood cells which have had dendritic cell reinfusion Volunteers are vaccinated at 0 1 3 and 6 month time points Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center Volunteers receive compensation benefits
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV 138 | None | None | None |