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Double-Blind Randomized Efficacy Field Trial of Alum Precipitated Autoclaved Leishmania Major (Alum-Alm) Vaccine Mixed With Bcg Plus Imiquimod Vs. Placebo Control Group



Barati M1, 2 ; Mohebali M1, 3 ; Alimohammadian MH4 ; Khmesipour A5 ; Keshavarz H1 ; Akhoundi B1 ; Zarei Z6
Authors
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Authors Affiliations
  1. 1. Dept. Of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Center for Research of Infectious Diseases, AJA University of Medical Sciences, Tehran, Iran
  3. 3. Center for Research of Endemic Parasites of Iran (CREPI), Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Dept. Of Immunology, Pasteur Institute of Iran, Tehran, Iran
  5. 5. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Meshkin-Shahr Research station, School of Public Health, Tehran University of Medical Sciences, Iran

Source: Iranian Journal of Parasitology Published:2015

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 × 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. © 2015, Tehran University of Medical Sciences (TUMS). All rights Reserved.
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