Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis

Tracking Information
First Submitted Date ICMJE	May 23, 2005
First Posted Date ICMJE	May 24, 2005
Last Update Posted Date	February 15, 2007
Study Start Date ICMJE	October 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: June 23, 2005)	Occurrence of dose limiting toxicity; Adverse events
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00111553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 23, 2005)	IgG and T-cell response to Leish-111f vaccine; Leish-111f skin test reactivity; Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
Official Title ICMJE	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
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 mg/kg, 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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Leishmaniasis, Cutaneous
Intervention ICMJE	Biological: Leish-111f + MPL-SE vaccine
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	45
Original Enrollment ICMJE	Same as current
Study Completion Date	August 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy; Normal lab values and electrocardiogram (ECG); Negative for HIV, hepatitis B and C, and Chagas disease Exclusion Criteria: Nine or more active cutaneous lesions; Lesion diameter >60mm; Previous exposure to Leishmania vaccines or to MPL-SE; Pregnant or breastfeeding female
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00111553
Other Study ID Numbers ICMJE	IDRI-LCVTC-101
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	IDRI
Collaborators ICMJE	Bill and Melinda Gates Foundation
Investigators ICMJE	Principal Investigator: Evaldo Nascimento, MD Federal University of Minas Gerais Study Director: Franco M Piazza, MD, MPH Infectious Disease Research Institute (IDRI)
PRS Account	IDRI
Verification Date	February 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP