Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369031
Status:
TERMINATED
Last Update Posted:
2008-04-15
First Post:
2006-08-24
Brief Title:
Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
A Phase I Open Label Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults
Status:
TERMINATED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety issues
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 whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant causes untoward adverse reactions when administered to healthy adult volunteers An initial evaluation of immune responses to the vaccine will also be undertaken
Detailed Description:
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant causes untoward adverse reactions when administered to healthy adult volunteers An initial evaluation of immune responses to the vaccine will also be undertaken by measuring gp140- and LTK63-specific IgG and IgA in cervical secretions vaginal secretions serum and nasal wash IFNg secretion of T cells in response to gp140 peptide stimulation will be undertaken along with neutralising assays
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 |
|---|---|---|---|
| FP6-2002-LIFESCIHEA-23 503240 | None | None | None |
| C86P1 | None | None | None |