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

被引：117

作者：

Chakravarty, Jaya ^{[2
]}

Kumar, Subodh ^{[2
]}

Trivedi, Sonali ^{[2
]}

Rai, Vijay K. ^{[2
]}

Singh, Anup ^{[2
]}

Ashman, Jill A. ^{[1
]}

Laughlin, Elsa M. ^{[1
]}

Coler, Rhea N. ^{[1
]}

Kahn, Stuart J. ^{[1
]}

Beckmann, Anna Marie ^{[1
]}

Cowgill, Karen D. ^{[1
]}

Reed, Steven G. ^{[1
]}

Sundar, Shyam ^{[2
]}

Piazza, Franco M. ^{[1
]}

机构：

[1] IDRI, Seattle, WA 98104 USA

[2] Banaras Hindu Univ, Inst Med Sci, Varanasi 221005, Uttar Pradesh, India

来源：

VACCINE | 2011年 / 29卷 / 19期

关键词：

Leishmaniasis vaccines; Adjuvants; Immunologic; Leishmaniasis; Visceral; CUTANEOUS LEISHMANIASIS; DONOVANI INFECTION; RISK-FACTORS; LIPID-A; INDIA; BIHAR; EPIDEMIOLOGY; COMBINATION; MANAGEMENT; ADJUVANT;

D O I：

10.1016/j.vaccine.2011.02.096

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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. (C) 2011 Elsevier Ltd. All rights reserved.

引用

页码：3531 / 3537

页数：7

共 30 条

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