title: Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania major (Alum-ALM) Vaccine Mixed With BCG Plus Imiquimod Vs. Placebo Control Group.
abstract: 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 × 10(6) 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 %.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran ; Center for Research of Infectious Diseases, AJA University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Barati
authors.affiliation: Dept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran ; Center for Research of Endemic Parasites of Iran (CREPI), Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mohebali
authors.affiliation: Dept. of Immunology, Pasteur Institute of Iran, Tehran, Iran.
authors.forename: Mohammad Hossein
authors.initials: MH
authors.lastname: Alimohammadian
authors.affiliation: Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Khmesipour
authors.affiliation: Dept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Keshavarz
authors.affiliation: Dept. of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Behnaz
authors.initials: B
authors.lastname: Akhoundi
authors.affiliation: Meshkin-Shahr Research station, School of Public Health, Tehran University of Medical Sciences, Iran.
authors.forename: Zabihollah
authors.initials: Z
authors.lastname: Zarei
keywords: Alum; BCG; Canine visceral leishmaniasis; Imiquimod; Iran; Leishmania major; Vaccine