Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000749
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
1999-11-02
Brief Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 CHO BIOCINE in MF59 Emulsion Versus the Emulsion Control Three Injections at 0 1 and 6 Months
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 CHO BIOCINE in MF59 Emulsion Versus the Emulsion Control Three Injections at 0 1 and 6 Months
Status:
COMPLETED
Status Verified Date:
2012-10
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:
To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0 1 and 6 months
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest
Detailed Description:
Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest
Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle Injections are given at months 0 1 and 6 Patients are followed for 12 months following the third injection
Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle Injections are given at months 0 1 and 6 Patients are followed for 12 months following the third injection
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?: