Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002402
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of AIDSVAX BB and AIDSVAX BE Two Possible Vaccines
Sponsor:
VaxGen
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase III Trial to Evaluate the Safety and Immunogenicity of AIDSVAX BB and BE Vaccines in the United States
Status:
COMPLETED
Status Verified Date:
1998-08
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 and effective to give AIDSVAX BB or AIDSVAX BE two potential HIV vaccines to HIV-negative volunteers
Detailed Description:
Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0 1 6 and 12 months
Arm A Patients receive 1 of 3 doses of AIDSVAX BB vaccine MN rgp120HIV-1 plus GNE8 rgp120HIV-1 in alum adjuvant
Arm B Patients receive AIDSVAX BE MN rgp120HIV-1 plus A244 rgp120HIV-1 vaccine in alum adjuvant
Patients are evaluated at 1 hr 3 days and 14 days after each immunization and at 18 months after the first immunization
An interim analysis is performed after all patients receive the second dose at 1 month
Arm A Patients receive 1 of 3 doses of AIDSVAX BB vaccine MN rgp120HIV-1 plus GNE8 rgp120HIV-1 in alum adjuvant
Arm B Patients receive AIDSVAX BE MN rgp120HIV-1 plus A244 rgp120HIV-1 vaccine in alum adjuvant
Patients are evaluated at 1 hr 3 days and 14 days after each immunization and at 18 months after the first immunization
An interim analysis is performed after all patients receive the second dose at 1 month
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?: