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

Leishmaniasis, Cutaneous Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111553
• Other study ID #: IDRI-LCVTC-101
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2005
• Last updated: February 13, 2007
• Start date: October 2004
• Est. completion date: August 2006

Study information

• Verified date: February 2007
• Source: IDRI
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Biological:
• Leish-111f + MPL-SE vaccine

Locations

Country	Name	City	State
Brazil	Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária	Januária	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
IDRI	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dose limiting toxicity
Primary	Adverse events
Secondary	IgG and T-cell response to Leish-111f vaccine
Secondary	Leish-111f skin test reactivity
Secondary	Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis