A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine for use in the prevention of visceral leishmaniasis

作者：Chakravarty Jaya; Kumar Subodh; Trivedi Sonali; Rai Vijay K; Singh Anup; Ashman Jill A; Laughlin Elsa M; Coler Rhea N; Kahn Stuart J; Beckmann Anna Marie; Cowgill Karen D; Reed Steven G; Sundar Shyam; Piazza Franco M^*

来源：Vaccine, 2011, 29(19): 3531-3537.

DOI：10.1016/j.vaccine.2011.02.096

• Leishmaniasis vaccines
• Adjuvants
• Immunologic
• Leishmaniasis
• Visceral

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 5 mu g, 10 mu g, or 20 mu g recombinant Leishmania polyprotein LEISH-F1 antigen +25 mu g MPL (R)-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-gamma 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.

• 出版日期2011-4-27
• 单位河北医科大学