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

Primary Purpose

Leishmaniasis, Cutaneous

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Leish-111f + MPL-SE vaccine

About this trial

This is an interventional treatment trial for Leishmaniasis, Cutaneous focused on measuring Leishmaniasis, Subunit vaccine, Therapeutic, T cell, Antimony

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidade Federal de Minas Gerais
Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária

Outcomes

Primary Outcome Measures

Occurrence of dose limiting toxicity

Adverse events

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00111553

First Posted

May 23, 2005

Last Updated

February 13, 2007

Sponsor

Access to Advanced Health Institute (AAHI)

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00111553

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Access to Advanced Health Institute (AAHI)

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leishmaniasis, Cutaneous

Keywords

Leishmaniasis, Subunit vaccine, Therapeutic, T cell, Antimony

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Leish-111f + MPL-SE vaccine

Primary Outcome Measure Information:

Title

Occurrence of dose limiting toxicity

Title

Adverse events

Secondary Outcome Measure Information:

Title

IgG and T-cell response to Leish-111f vaccine

Title

Leish-111f skin test reactivity

Title

Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evaldo Nascimento, MD

Organizational Affiliation

Federal University of Minas Gerais

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Franco M Piazza, MD, MPH

Organizational Affiliation

Infectious Disease Research Institute (IDRI)

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal de Minas Gerais

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

31270-901

Country

Brazil

Facility Name

Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária

City

Januária

State/Province

Minas Gerais

ZIP/Postal Code

39480-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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