Randomized, controlled, double-blinded field trial to assess Leishmania vaccine effectiveness as immunotherapy for canine leishmaniosis

Angela Toepp; Mandy Larson; Geneva Wilson; Tara Grinnage-Pulley; Carolyne Bennett; Adam Leal-Lima; Bryan Anderson; Molly Parrish; Michael Anderson; Hailie Fowler; Jessica Hinman; Eric Kontowicz; Jane Jefferies; Marvin Beeman; Jesse Buch; Jill Saucier; Phyllis Tyrrell; Radhika Gharpure; Caitlin Cotter; Christine Petersen

doi:10.1016/j.vaccine.2018.08.087

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Randomized, controlled, double-blinded field trial to assess Leishmania vaccine effectiveness as immunotherapy for canine leishmaniosis

Journal article

Peer reviewed

Randomized, controlled, double-blinded field trial to assess Leishmania vaccine effectiveness as immunotherapy for canine leishmaniosis

Angela Toepp, Mandy Larson, Geneva Wilson, Tara Grinnage-Pulley, Carolyne Bennett, Adam Leal-Lima, Bryan Anderson, Molly Parrish, Michael Anderson, Hailie Fowler, …

Vaccine, Vol.36(43), pp.6433-6441

10/15/2018

DOI: 10.1016/j.vaccine.2018.08.087

PMID: 30219369

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Abstract

•Blinded clinical field trial.•Anti-Leishmania vaccine as immunotherapy significantly reduced clinical progression.•Vaccine decreased mortality in Leishmania infantum-infected, healthy, dogs. Better tools are necessary to eliminate visceral leishmaniasis (VL). Modeling studies for regional Leishmania elimination indicate that an effective vaccine is a critical tool. Dogs are the reservoir host of L. infantum in Brazil and the Mediterranean basin, and therefore are an important target for public health interventions as well as a relevant disease model for human VL. No vaccine has been efficacious as an immunotherapy to prevent progression of already diagnostically positive individuals to symptomatic leishmaniasis. We performed a double-blinded, block-randomized, placebo-controlled, vaccine immunotherapy trial testing the efficacy of a recombinant Leishmania A2 protein, saponin-adjuvanted, vaccine, LeishTec®, in owned hunting dogs infected with L. infantum. The primary outcome was reduction of clinical progression, with reduction of mortality as a secondary outcome. Vaccination as an immunotherapy reduced the risk of progression to clinically overt leishmaniasis by 25% in asymptomatic dogs (RR: 1.33 95% C.I. 1.009–1.786 p-value: 0.0450). Receiving vaccine vs. placebo reduced all-cause mortality in younger asymptomatic dogs by 70% (RR: 3.19 95% C.I.: 1.185–8.502 p-value = 0.0245). Vaccination of infected-healthy animals with an anti-Leishmania vaccine significantly reduced clinical progression and decreased all-cause mortality. Use of vaccination in infected-healthy dogs can be a tool for Leishmania control.

Leishmania

Immunotherapy

Zoonoses

Canine

Details

Title: Subtitle: Randomized, controlled, double-blinded field trial to assess Leishmania vaccine effectiveness as immunotherapy for canine leishmaniosis
Creators: Angela Toepp - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Mandy Larson - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Geneva Wilson - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Tara Grinnage-Pulley - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Carolyne Bennett - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Adam Leal-Lima - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Bryan Anderson - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Molly Parrish - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Michael Anderson - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Hailie Fowler - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Jessica Hinman - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Eric Kontowicz - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Jane Jefferies - Noah’s Ark Animal Clinic, Kansas City, MO, USA
Marvin Beeman - Littleton Equine Hospital, Littleton, CO, USA
Jesse Buch - IDEXX Laboratories Inc., Westbrook, ME, USA
Jill Saucier - IDEXX Laboratories Inc., Westbrook, ME, USA
Phyllis Tyrrell - IDEXX Laboratories Inc., Westbrook, ME, USA
Radhika Gharpure - Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21210, USA
Caitlin Cotter - Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21210, USA
Christine Petersen - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA 52242, USA
Resource Type: Journal article
Publication Details: Vaccine, Vol.36(43), pp.6433-6441
DOI: 10.1016/j.vaccine.2018.08.087
PMID: 30219369
NLM abbreviation: Vaccine
ISSN: 0264-410X
eISSN: 1873-2518
Publisher: Elsevier Ltd
Language: English
Date published: 10/15/2018
Academic Unit: Molecular Physiology and Biophysics; Epidemiology; Pharmacy Practice and Science; Internal Medicine; Ophthalmology and Visual Sciences
Record Identifier: 9983995022202771

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