Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01011309
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2009-11-09
Brief Title:
A Study of the Efficacy and Safety of the LEISH-F2 MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
Official Title:
A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy Safety and Immunogenicity of the LEISH-F2 MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The purpose of this study is to determine the efficacy safety and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis including cutaneous leishmaniasis CL The vaccine identified as LEISH-F2 MPL-SE consists of a Leishmania protein LEISH-F2 together with an adjuvant MPL-SE
Detailed Description:
A phase 2 randomized open-label controlled study to evaluate the efficacy safety and immunogenicity of the vaccine administered three times 10 μg LEISH-F2 25 μg MPL-SE on Days 0 28 and 56 in the treatment of adults and adolescents with CL compared to treatment with standard chemotherapy 20 mgkgday sodium stibogluconate for 20 days The proportion cured in each group will be determined using clinical criteria
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