title: A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine for use in the prevention of visceral leishmaniasis.
abstract: Healthy Indian adult volunteers, with or without a history of leishmaniasis, were evaluated for evidence of previous infection with Leishmania donovani based on the direct agglutination test (DAT). Three cohorts of 6 DAT-negative and 6 DAT-positive subjects were enrolled in an open-label, dose-escalating, uncontrolled clinical trial and received three injections of the LEISH-F1+MPL-SE vaccine (consisting of 5μg, 10μg, or 20μg recombinant Leishmania polyprotein LEISH-F1 antigen+25μg MPL®-SE adjuvant). The study injections were given subcutaneously on days 0, 28, and 56, and the subjects were followed through day 168 for safety and immunological endpoints. The vaccine was safe and well-tolerated in DAT-negative and DAT-positive subjects and induced T-cell production of IFN-γ and other cytokines in response to stimulation with the LEISH-F1 antigen. This clinical trial shows that the LEISH-F1+MPL-SE vaccine is safe and immunogenic in healthy subjects with and without history of previous infection with Leishmania donovani.
authors.affiliation: Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
authors.forename: Jaya
authors.initials: J
authors.lastname: Chakravarty
authors.forename: Subodh
authors.initials: S
authors.lastname: Kumar
authors.forename: Sonali
authors.initials: S
authors.lastname: Trivedi
authors.forename: Vijay K
authors.initials: VK
authors.lastname: Rai
authors.forename: Anup
authors.initials: A
authors.lastname: Singh
authors.forename: Jill A
authors.initials: JA
authors.lastname: Ashman
authors.forename: Elsa M
authors.initials: EM
authors.lastname: Laughlin
authors.forename: Rhea N
authors.initials: RN
authors.lastname: Coler
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: Shyam
authors.initials: S
authors.lastname: Sundar
authors.forename: Franco M
authors.initials: FM
authors.lastname: Piazza
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000328:Adult; D016207:Cytokines / Q000096:biosynthesis; D005260:Female; D006801:Humans; D007111:Immunity, Cellular; D007115:Immunization Schedule; D007891:Leishmania / Q000276:immunology; D054332:Leishmaniasis Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D007898:Leishmaniasis, Visceral / Q000517:prevention & control*; D008050:Lipid A / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D016207:Cytokines; D054332:Leishmaniasis Vaccines; D008050:Lipid A; C048436:monophosphoryl lipid A