Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111514
Status:
COMPLETED
Last Update Posted:
2007-02-15
First Post:
2005-05-20
Brief Title:
Study to Evaluate the Leish-111F MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Dose-Escalating Study to Evaluate Safety Tolerability and Immunogenicity of Leish-111f MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis
Status:
COMPLETED
Status Verified Date:
2007-02
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:
The purpose of this study is to evaluate the safety of the Leish-111f MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis
Detailed Description:
Mucosal leishmaniasis is a disfiguring and possibly fatal infection All available medical therapies require weeks of treatment and cause significant toxicity In Peru the standard therapy is daily intravenous IV pentavalent antimony 20 mgkgday for 28 days It appears that Leishmania infections can be eliminated by T helper 1 immune responses These findings argue that a vaccine that augments mucosal leishmaniasis patients T helper 1 responses will eliminate the infection and disease This study is a phase 1 randomized double-blind placebo controlled sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5 10 or 20 μg of Leish-111f protein 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent antimony 20 mgkgday for 28 days in patients with mucosal leishmaniasis
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