Iranian Journal of Parasitology 2015. 10(3):351-359.

Double-Blind Randomized Efficacy Field Trial of Alum Precipi¬tated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group
Mohammad BARATI, Mehdi MOHEBALI, Mohammad Hossein ALIMOHAM¬MADIAN, Ali KHMESIPOUR, Hossein KESHAVARZ, Behnaz AKHOUNDI, Zabi¬hollah ZAREI


Background: Canine visceral leishmaniasis (CVL) is not only an emerging veterinary concern but also a public health threat in endemic areas. The aim of this study was to assess the efficacy, immunogenicity and safety of two doses of aluminum hydroxide (alum) precipitated Leishmania major (Alum-ALM) mixed with BCG plus imiquimod against CVL.

Methods: A total of 560 ownership dogs were serologically tested and 234 healthy dogs with no clinical signs of CVL, no anti-Leishmania antibodies and negative leish­manin skin test were selected and double-blind randomly injected intradermally either with 0.1 ml Alum-ALM (200µg protein) mixed with BCG (2 × 106 CFUs) plus imiquimod (121 dogs) or with 0.1 ml of normal saline (113 dogs).

Results: The follow-up examinations showed that there was no side effect associated with the vaccination except one case. Strong skin test conversion were seen in vac­cinated group (30.3%) compared to the control group (6.6%) at 22-24 weeks after the booster injection (p<0.001). The seroconversion was 16.3% (18/110) in vaccinated group and 26.4% (28/106) in control group after two transmission cycles but the differ­ence was not significant (P=0.095). The efficacy rate based on seroconversion was 40.4 %.

Conclusion: Two injections of Alum-ALM mixed with BCG and imiquimod is safe, although decreases the seroconversion rate of CVL, but the overall efficacy was low.


Alum; Leishmania major; Vaccine; Canine visceral leish-maniasis; BCG; Imiquimod; Iran

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