Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111553
Status:
COMPLETED
Last Update Posted:
2007-02-15
First Post:
2005-05-23
Brief Title:
Study to Evaluate the Leish-111F MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
Official Title:
Randomized Double-Blind Adjuvant- and Placebo-Controlled Dose-Escalating Study to Evaluate Safety Tolerability and Immunogenicity of Leish-111f MPL-SE Vaccine With Meglumine Antimoniate Glucantime in Cutaneous 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:
This study will evaluate the safety of the Leish-111f MPL-SE vaccine in adult patients with cutaneous leishmaniasis
Detailed Description:
Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis a more serious and possibly fatal form of leishmania infection All available medical therapies require weeks of treatment and cause significant toxicity In Brazil a standard therapy is Glucantime treatment administered in cycles of 10 consecutive once daily intramuscular injections Glucantime 10 mgkg maximum of 850 mg followed by 11 consecutive days without Glucantime injections rest days At the completion of each cycle a study physician examines the patient to determine if a further cycle of Glucantime treatment is indicated
It appears that Leishmania infections can be eliminated by T helper 1 immune responses This finding argues that a vaccine that augments cutaneous leishmaniasis patients T helper 1 response 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 the standard chemotherapy with Glucantime cycles as described above in patients with cutaneous leishmaniasis
It appears that Leishmania infections can be eliminated by T helper 1 immune responses This finding argues that a vaccine that augments cutaneous leishmaniasis patients T helper 1 response 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 the standard chemotherapy with Glucantime cycles as described above in patients with cutaneous 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