title: Double-blind randomized efficacy field trial of alum precipitated autoclaved Leishmania major vaccine mixed with BCG against canine visceral leishmaniasis in Meshkin-Shahr district, I.R. Iran.
abstract: This study was designed to evaluate the efficacy of a single dose of aluminum hydroxide (alum) precipitated Leishmania major (Alum-ALM) vaccine plus BCG against canine visceral leishmaniasis. Three hundred and forty-seven healthy dogs with no anti-Leishmania antibodies were double-blind randomly injected intradermally with either 0.1ml of Alum-ALM (200 microg protein) mixed with BCG (182 dogs) or injected with 0.1ml of normal saline (165 dogs). The results of 16 months follow-up showed that the vaccine was safe and well-tolerated. Strong seroconversion using DAT and ELISA techniques at 16 months post-vaccination was considered as an indication of Leishmania infection. The incidence rate was 3.7% (6/162) in vaccinated group and 12.0% (17/141) in control group using DAT technique. The efficacy of the vaccine was calculated to be 69.3%.
authors.affiliation: School of Public Health and Institute of Public Health Research, Tehran University of Medical Sciences, Iran. mmohebali@hotmail.com
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mohebali
authors.forename: Ali
authors.initials: A
authors.lastname: Khamesipour
authors.forename: Iraj
authors.initials: I
authors.lastname: Mobedi
authors.forename: Zabih
authors.initials: Z
authors.lastname: Zarei
authors.forename: Reza
authors.initials: R
authors.lastname: Hashemi-Fesharki
mesh_terms: D000276:Adjuvants, Immunologic; D000536:Aluminum Hydroxide; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D004283:Dog Diseases / Q000276:immunology / Q000517:prevention & control*; D004285:Dogs; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D007271:Injections, Intradermal; D007492:Iran; D007898:Leishmaniasis, Visceral / Q000276:immunology / Q000517:prevention & control / Q000662:veterinary*; D008297:Male; D016052:Protozoan Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014611:Vaccination / Q000009:adverse effects / Q000662:veterinary
chemical_list: D000276:Adjuvants, Immunologic; D000913:Antibodies, Protozoan; D001500:BCG Vaccine; D016052:Protozoan Vaccines; D000536:Aluminum Hydroxide