Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440544
Status:
TERMINATED
Last Update Posted:
2008-11-02
First Post:
2007-02-26
Brief Title:
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine Ag85B-ESAT6
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine Ag85B-ESAT6 LTK63 Administered at 0 and 2 Months
Status:
TERMINATED
Status Verified Date:
2008-10
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:
TMUVA-01
Brief Summary:
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M tuberculosis virus mixed with a toxoid adjuvant causes untoward adverse reactions when administered to healthy adult volunteers Both subjects who have not received Bacillus Calmette-Guerin BCG and subjects who have already received BCG will be enrolled An initial evaluation of immune responses to the vaccine will also be undertaken
Detailed Description:
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M tuberculosis virus mixed with a toxoid adjuvant causes untoward adverse reactions when administered to healthy adult volunteers Both subjects who have not received BCG and subjects who have already received BCG will be enrolled An initial evaluation of immune responses to the vaccine will also be undertaken using flow cytometry to enumerate antigen specific IFNg containing T cells ELISPOT to determine IFNg secreting antigen specific T cells serology and nasal wash antibody
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 |
| EudraCT Number 2005-005140-81 | None | None | None |