Evidence map›Paper›PMID 25299614›Full record

Trial reportPLoS neglected tropical diseases2014

A randomised, double-blind, controlled efficacy trial of the LiESP/QA-21 vaccine in naïve dogs exposed to two leishmania infantum transmission seasons.

Gaetano Oliva, Javier Nieto, Valentina Foglia Manzillo, Silvia Cappiello, Eleonora Fiorentino, Trentina Di Muccio, Aldo Scalone, Javier Moreno, Carmen Chicharro, Eugenia Carrillo and 8 more

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
10.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. LmCenNPJ vaccines · 2025
    Article
  11. An update on recombinant vaccines against leishmaniasis.The Indian journal of medical research · 2024
    Review
  12. Review
  13. Review
  14. Vaccines · 2022
    Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

18 authors at 5 institutions in 3 countries.

Gaetano OlivaDepartment of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
Javier NietoLeishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Valentina Foglia ManzilloDepartment of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
Silvia CappielloDepartment of Veterinary Clinical Sciences, University Federico II, Naples, Italy.
Eleonora FiorentinoUnit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
Trentina Di MuccioUnit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
Aldo ScaloneUnit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
Javier MorenoLeishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Carmen ChicharroLeishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Eugenia CarrilloLeishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Therese ButaudSafety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
Laurie GuegandSafety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
Virginie MartinSafety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
Anne-Marie CuisinierSafety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
David McGahieMedical Department, VIRBAC, Carros, France.
Sylvie GueguenSafety and Efficacy Unit, Biological R&D, VIRBAC BIO3, Carros, France.
Carmen CañavateLeishmaniasis and Chagas Disease Unit, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
Luigi GradoniUnit of Vector-borne Diseases and International Health, MIPI Department, Istituto Superiore di Sanità, Rome, Italy.
Virbac (France) · FRInstituto de Salud Carlos III · ESIstituto Superiore di Sanità · ITFederico II University Hospital · ITCentro Nacional de Microbiologia · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Canine leishmaniasis is an important zoonosis caused by uncontrolled infection with Leishmania infantum, where an inappropriate immune response is not only responsible for permitting this intracellular parasite to multiply, but is also responsible for several of the pathological processes seen in this disease. Effective canine vaccines are therefore a highly desirable prevention tool. In this randomised, double-blinded, controlled trial, the efficacy of the LiESP/QA-21 vaccine (CaniLeish, Virbac, France) was assessed by exposing 90 naïve dogs to natural L. infantum infection during 2 consecutive transmission seasons, in two highly endemic areas of the Mediterranean basin. Regular PCR, culture, serological and clinical examinations were performed, and the infection/disease status of the dogs was classified at each examination. The vaccine was well-tolerated, and provided a significant reduction in the risk of progressing to uncontrolled active infection (p = 0.025) or symptomatic disease (p = 0.046), with an efficacy of 68.4% and a protection rate of 92.7%. The probability of becoming PCR positive was similar between groups, but the probability of returning to a PCR negative condition was higher in the vaccinated group (p = 0.04). In conclusion, we confirmed the interest of using this vaccine as part of a comprehensive control program for canine leishmaniasis, and validated the use of a protocol based on regular in-depth assessments over time to assess the efficacy of a canine leishmaniasis vaccine.

Indexed as

AnimalsDog DiseasesDogsDouble-Blind MethodEndemic DiseasesFemaleInsect VectorsItalyLeishmania infantumLeishmaniasis VaccinesLeishmaniasis, VisceralMalePhlebotomusSpainLeishmaniasis Vaccines

Identifiers

PMID25299614
PMCPMC4191955
OpenAlexW2026685638

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.