| Literature DB >> 15003662 |
R X Armijos1, M M Weigel, M Calvopina, A Hidalgo, W Cevallos, J Correa.
Abstract
The safety, immunogenecity, and efficacy of two doses of an autoclaved-killed, whole cell Leishmania amazonensis vaccine (IFLA/BR/67/PH8) and BCG adjuvant (n = 750) against cutaneous leishmaniasis (CL) was compared with placebo (n = 756) in a randomized, placebo-controlled, blinded study. Systemic and local side-effects were more frequent in the vaccine than placebo group. Leishmanin skin test (LST) conversion was greater in the vaccine than placebo group 2 months after the second vaccination dose (74.4% versus 14.7%; P = 0.000001). The 26-month incidence of confirmed CL (n = 25) was similar between the vaccine (2.0%) and placebo groups (2.0% versus 1.3%; P > 0.05). LST conversion was not associated with CL protection and the vaccine did not offer significant protection against CL infection caused by L. Viannia spp. compared to placebo.Entities:
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Year: 2004 PMID: 15003662 DOI: 10.1016/j.vaccine.2003.06.002
Source DB: PubMed Journal: Vaccine ISSN: 0264-410X Impact factor: 3.641