当前位置： SCI文献检索 > VACCINE期刊下所有文献 > 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.

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.

journal_name

Vaccine

journal_title

Vaccine

authors

Llanos-Cuentas A,Calderón W,Cruz M,Ashman JA,Alves FP,Coler RN,Bogatzki LY,Bertholet S,Laughlin EM,Kahn SJ,Beckmann AM,Cowgill KD,Reed SG,Piazza FM

doi

10.1016/j.vaccine.2010.08.092

subject

Has Abstract

pub_date

2010-10-28 00:00:00

pages

7427-35

issue

46

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(10)01274-0

journal_volume

28

pub_type

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