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.

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%.