Clinical trial NCT00111553: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leishmaniasis, Cutaneous
Keywords: Leishmaniasis
Subunit vaccine
Therapeutic
T cell
Antimony
Lead sponsor: Access to Advanced Health Institute (AAHI)
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2005-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Occurrence of dose limiting toxicity
measure: Adverse events
Secondary outcomes:
measure: IgG and T-cell response to Leish-111f vaccine
measure: Leish-111f skin test reactivity
measure: Safety of the vaccine with respect to the clinical course of cutaneous leishmaniasis
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
city: Januária
country: Brazil
facility: Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Evaldo Nascimento, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Disease Research Institute (IDRI)
name: Franco M Piazza, MD, MPH
role: STUDY_DIRECTOR
References: