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

NCT ID: NCT00111553

Last Updated: 2007-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-08-31

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.

Conditions

Leishmaniasis, Cutaneous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Leish-111f + MPL-SE vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Access to Advanced Health Institute (AAHI)

OTHER

Sponsor Role: lead

Principal Investigators

Evaldo Nascimento, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Franco M Piazza, MD, MPH

Role: STUDY_DIRECTOR

Infectious Disease Research Institute (IDRI)

Locations

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária

Januária, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

IDRI-LCVTC-101

Identifier Type: -

Identifier Source: org_study_id