Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121862
Status:
COMPLETED
Last Update Posted:
2006-05-05
First Post:
2005-07-18
Brief Title:
Study to Evaluate the Leish-111f MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
Official Title:
A Study to Evaluate the Safety Tolerability and Immunogenicity of the Leish-111f MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative 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 and immunogenicity of the Leish-111f MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite
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 2 randomized double blind placebo-controlled study to evaluate the safety tolerability and immunogenicity in Montenegro skin test MST-negative 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 In addition the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein 10 μg given alone The vaccine Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals
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 2 randomized double blind placebo-controlled study to evaluate the safety tolerability and immunogenicity in Montenegro skin test MST-negative 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 In addition the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein 10 μg given alone The vaccine Leish-111f protein alone or placebo 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