A systematic review of the efficacy of prophylactic control measures for naturally-occurring canine leishmaniosis, part I: vaccinations.

Canine leishmaniosis (CanL) is an important zoonotic disease; however, the efficacy of available vaccines for the prevention of naturally-occurring Leishmania infantum (L. infantum) infection in dogs remains unclear. The objective of this review was to determine the efficacy of currently available vaccines to prevent naturally-occurring L. infantum infection in dogs. Four bibliographic databases (CAB Direct 2011, Web of Science 2011, U.S. National Library of Medicine 2011 and Literatura Latino Americana e do Caribe em Ciências da Saúde) were searched along with eight sets of conference proceedings and the International Veterinary Information Service (IVIS) database, from 1980 to November 2012. Randomised controlled trials (RCTs), non-randomised clinical trials (NRCTs), cohort studies and case-control studies that investigated vaccine efficacy for natural L. infantum infection in dogs were eligible for inclusion. Two review authors independently assessed each study against the inclusion criteria, independently extracted relevant data from all included studies and assessed the risk of methodological shortcomings in each individual study. The odds ratio (OR) and absolute risk reduction (ARR) for dichotomous outcomes and mean difference for continuous outcomes were calculated. Meta-analysis was not performed due to heterogeneity of the studies identified. The search was conducted for all mitigations for CanL and yielded the title and abstract of 937 articles, from which 84 articles were screened based on full text. Twelve studies on vaccinations (five RCTs, seven NRCTs) were identified. Ten studies were at a high risk of methodological shortcomings, whilst two were at an unclear risk. The use of 200 μg ALM protein, Leishmune(®), CaniLeish(®), LiESAp with MDP, and ALM with BCG tended to significantly reduce the proportion of dogs infected with L. infantum based on either parasitological or serological evidence. The use of lyophilized protein vaccine significantly increased the proportion of dogs infected with L. infantum based on either parasitological or serological evidence. There is peer-reviewed evidence that control measures are effective in preventing CanL with the results suggesting that between 6 and 54% of infections could be prevented with vaccination. However, this evidence is based on a small number of RCTs, all of which are either at high or unclear risk of methodological shortcomings. Well-designed, adequately powered and properly reported randomised clinical trials are needed to clearly establish efficacy of vaccines as CanL control measures.