A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1 + MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis

Abstract Adult patients with mucosal leishmaniasis (ML) were enrolled in a randomized, double-blind, placebo-controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania...

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Bibliographic Details
Published in:Vaccine 2010-10, Vol.28 (46), p.7427-7435
Main Authors: Llanos-Cuentas, Alejandro, Calderón, Wessmark, Cruz, María, Ashman, Jill A, Alves, Fabiana P, Coler, Rhea N, Bogatzki, Lisa Y, Bertholet, Sylvie, Laughlin, Elsa M, Kahn, Stuart J, Beckmann, Anna Marie, Cowgill, Karen D, Reed, Steven G, Piazza, Franco M
Format: Article
Language:English
Subjects:
Adjuvants
Adult
Allergy and Immunology
Antibodies, Protozoan - blood
Antibodies, Protozoan - immunology
Antibody Formation
Antigens
Antigens, Protozoan - immunology
Antimony Sodium Gluconate - administration & dosage
Antimony Sodium Gluconate - therapeutic use
Antiprotozoal Agents - administration & dosage
Antiprotozoal Agents - therapeutic use
Applied microbiology
Biological and medical sciences
Chemotherapy
Chronic illnesses
Clinical trials
Cytokines - immunology
Double-Blind Method
Endpoint Determination
Female
Fundamental and applied biological sciences. Psychology
HIV
Human immunodeficiency virus
Human protozoal diseases
Humans
Immunogenicity
Immunoglobulin G - blood
Immunoglobulin G - immunology
Immunologic
Infectious diseases
Laboratories
Leishmania
Leishmaniasis
Leishmaniasis vaccines
Leishmaniasis Vaccines - administration & dosage
Leishmaniasis Vaccines - adverse effects
Leishmaniasis Vaccines - immunology
Leishmaniasis, Mucocutaneous - immunology
Leishmaniasis, Mucocutaneous - prevention & control
Leshmaniasis
Male
Medical sciences
Microbiology
Middle Aged
Mucosal
Parasitic diseases
Protozoal diseases
Sodium
Th1 Cells - immunology
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vector-borne diseases
Young Adult
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Summary:Abstract Adult patients with mucosal leishmaniasis (ML) were enrolled in a randomized, double-blind, placebo-controlled, dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1 + MPL-SE vaccine (consisting of 5, 10, or 20 μg recombinant Leishmania polyprotein LEISH-F1 antigen + 25 μg MPL® -SE adjuvant) ( n = 36) or saline placebo ( n = 12). The study injections were given subcutaneously on Days 0, 28, and 56, and the patients were followed through Day 336 for safety, immunological, and clinical evolution endpoints. All patients received standard chemotherapy with sodium stibogluconate starting on Day 0. The vaccine was safe and well tolerated, and induced both humoral and cell-mediated immune responses. Furthermore, intracellular cytokine staining showed an increase in the proportion of memory LEISH-F1-specific IL-2+ CD4 T-cells after vaccination, which was associated with clinical cure. This clinical trial shows that the LEISH-F1 + MPL-SE vaccine is safe and immunogenic in patients with ML.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2010.08.092