title: 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 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.
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Llanos-Cuentas
authors.forename: Wessmark
authors.initials: W
authors.lastname: Calderón
authors.forename: María
authors.initials: M
authors.lastname: Cruz
authors.forename: Jill A
authors.initials: JA
authors.lastname: Ashman
authors.forename: Fabiana P
authors.initials: FP
authors.lastname: Alves
authors.forename: Rhea N
authors.initials: RN
authors.lastname: Coler
authors.forename: Lisa Y
authors.initials: LY
authors.lastname: Bogatzki
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bertholet
authors.forename: Elsa M
authors.initials: EM
authors.lastname: Laughlin
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Kahn
authors.forename: Anna Marie
authors.initials: AM
authors.lastname: Beckmann
authors.forename: Karen D
authors.initials: KD
authors.lastname: Cowgill
authors.forename: Steven G
authors.initials: SG
authors.lastname: Reed
authors.forename: Franco M
authors.initials: FM
authors.lastname: Piazza
mesh_terms: D000328:Adult; D000913:Antibodies, Protozoan / Q000097:blood / Q000276:immunology; D000917:Antibody Formation; D000953:Antigens, Protozoan / Q000276:immunology*; D000967:Antimony Sodium Gluconate / Q000008:administration & dosage / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016207:Cytokines / Q000276:immunology; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D054332:Leishmaniasis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007897:Leishmaniasis, Mucocutaneous / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D018417:Th1 Cells / Q000276:immunology; D055815:Young Adult
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan; D000981:Antiprotozoal Agents; D016207:Cytokines; D007074:Immunoglobulin G; D054332:Leishmaniasis Vaccines; D000967:Antimony Sodium Gluconate