Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121849
Status:
COMPLETED
Last Update Posted:
2006-05-05
First Post:
2005-07-15
Brief Title:
Safety Study to Evaluate the Leish-111f MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Safety Tolerability and Immunogenicity of the Leish-111f MPL-SE Vaccine in Montenegro Skin Test-Positive Healthy Adults
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety of the Leish-111f MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite but without current or past history of leishmaniasis
Detailed Description:
Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis a more serious and possibly fatal form of Leishmania disease All available medical therapies require weeks of treatment and cause significant toxicity It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease This is a phase 1 open-label study to evaluate the safety tolerability and immunogenicity in Montenegro skin test MST-positive healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis The vaccine identified as Leish-111f MPL-SE consists of a recombinant three-antigen Leishmania polyprotein Leish-111f 10 μg together with the adjuvant MPL-SE 25 μg The vaccine will be given to each study subject three times at 4 week intervals
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