A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis

NCT01011309 | Completed Phase 2 Results DMC

• 1 other identifier: IDRI-LCVTC-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.

Conditions

Cutaneous Leishmaniasis

Keywords

Leishmaniasis; vaccine; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Date of Clinical Cure

  Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.

  Day 84

• Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.

  Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.

  Day 0 through Day 84

Secondary Outcomes (1)

• IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)

  Days 0, 56 or 84, and 168

Study Arms (2)

LEISH-F2 + MPL-SE vaccine

EXPERIMENTAL

Recombinant three antigen Leishmania polyprotein + MPL-SE adjuvant

Biological: LEISH-F2 + MPL-SE

Sodium stibogluconate (SSG)

ACTIVE COMPARATOR

20 mg/kg/day IV for 20 days

Drug: Sodium stibogluconate

Interventions

LEISH-F2 + MPL-SE BIOLOGICAL

10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56

Also known as: There are no other names for the vaccine.

LEISH-F2 + MPL-SE vaccine

Sodium stibogluconate DRUG

20 mg/kg/day IV daily for 20 days

Also known as: Marfan SSG

Sodium stibogluconate (SSG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 12 years and \< 70 years of age. In the first stage of the study, only patients aged ≥ 18 years and \< 70 years will be enrolled. In the second stage, enrollment will also include adolescent patients aged ≥ 12 - \< 18 years.
• Must have a clinical diagnosis of cutaneous leishmaniasis confirmed by positive identification of Leishmania parasite and identification of L. peruviana by PCR.
• Lesions must be clear of any superinfection prior to enrollment.
• Female patients of childbearing age must have a negative serum pregnancy test at screening, a negative urine pregnancy test within 24 hours before the first vaccination or initiation of chemotherapy, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that LEISH-F2 + MPL SE, sodium stibogluconate might have in a fetus or newborn infant.
• The following laboratory blood tests must have values within the normal ranges at screening: sodium, potassium, urea, total bilirubin, ALT, AST, glucose, creatinine, alkaline phosphatase, total WBC count and platelet count. Hemoglobin may exceed the ULN since patients reside in the Andes at very high altitude (up to 20 g/dL)
• The following serology tests must be negative at screening: HIV-1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All patients (or their parents) will receive HIV-related counseling prior to testing. Patients with positive HIV test results will be referred for counseling and treatment as appropriate.
• Potential study patients (or their guardians) must give written informed consent, be willing to be housed in Lima for a minimum of 20 days and up to 63 days, able to attend all required follow-up visits, have a permanent address, and be reachable by study site personnel.

You may not qualify if:

• Infection with species other than L.peruviana as confirmed by PCR.
• Presence of eleven or more active cutaneous leishmaniasis lesions.
• The diameter of the ulcerated area of any single lesion is \>60 mm.
• Presence of lesions with superinfection at time of enrollment.
• History of mucocutaneous leishmaniasis or diagnosis of mucocutaneous leishmaniasis at screening.
• History of previous exposure to Leishmania vaccines.
• Known use of injected or oral corticosteroids within 6 weeks prior to the first vaccination or initiation of chemotherapy.
• Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first vaccination or initiation of chemotherapy.
• History of autoimmune disease or other causes of immunosuppressive states.
• History or evidence of any acute or chronic illness that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Patients presenting with concomitant illness will be referred for standard clinical care).
• History of use of any medication that, in the opinion of the study clinician, may interfere with the evaluation of the safety or the immunogenicity of the vaccine.
• History of significant psychiatric illness.
• Drug addiction including alcohol abuse.
• Patients with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs.
• Patients who are unlikely to cooperate with the requirements of the study protocol.

Sponsors & Collaborators

• Access to Advanced Health Institute (AAHI): lead

Study Sites (1)

Instituto de Medicina Tropical"Alexander von Humboldt"

Lima, Peru

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Interventions

Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Limitations and Caveats

A total of 150 patients was planned, including age de-escalation to adolescents after the first 60 adults enrolled. Owing to slow recruitment and insufficient evidence of efficacy in the immunotherapy group, enrollment was closed early.

Results Point of Contact

• Title: Jill Ashman, MSc, Associate Director of Clinical Operations
• Organization: IDRI

jill.ashman@idri.org

206-858-6041

Study Officials

• Franco Piazza, MD, MPH

  Access to Advanced Health Institute (AAHI)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 11, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 11, 2013
• Results First Posted: November 18, 2013

Record last verified: 2013-11

Locations

PE (1)