March 05, 2018

Safety Analysis of Leishmania Vaccine Used in a Randomized Canine Vaccine/Immunotherapy Trial

By Molly Parrish

In Leishmania infantum–endemic countries, controlling infection within dogs, the domestic reservoir, is critical to public health. There is a need for safe vaccines that prevent canine progression with disease and transmission to others. Protective vaccination against Leishmania requires mounting a strong, inflammatory, Type 1 response. Three commercially available canine vaccines on the global veterinary market use saponin or inflammatory antigen components (Letifend) as a strong pro-inflammatory adjuvant. There is very little information detailing safety of saponin as an adjuvant in field trials. Safety analyses for the use of vaccine as an immunotherapeutic in asymptomatically infected animals are completely lacking. Leishmania infantum, the causative agent of canine leishmaniasis, is enzootic within U.S. hunting hounds. We assessed the safety of LeishTec® after use in dogs from two different clinical states: 1) without clinical signs and tested negative on polymerase chain reaction and serology or 2) without clinical signs and positive for at least one Leishmania diagnostic test. Vaccine safety was assessed after all three vaccinations to quantify the number and severity of adverse events. Vaccinated animals had an adverse event rate of 3.09%, whereas placebo animals had 0.68%. Receiving vaccine was correlated with the occurrence of mild, site-specific, reactions. Occurrence of severe adverse events was not associated with having received vaccine. Infected, asymptomatic animals did not have a higher rate of adverse events. Use of vaccination is, therefore, likely to be safe in infected, asymptomatic animals.

Read the full article in The American of Tropical Medicine and Hygiene.

  • Podcast
    • January 28, 2020
    Building the World’s Biggest Budget

    What do the Pentagon's decisions about military spending say about our priorities as a nation? What goes into the DoD's $700 billion budget each year? Former Pentagon official...

    By Ilan Goldenberg & Susanna V. Blume

  • Reports
    • January 28, 2020
    Rising to the China Challenge

    An independent assessment for Congress as mandated by the FY2019 National Defense Authorization Act....

    By Ely Ratner, Daniel Kliman, Susanna V. Blume, ​Rush Doshi, Chris Dougherty, Richard Fontaine, Peter Harrell, Martijn Rasser, Elizabeth Rosenberg, Eric Sayers, Daleep Singh, Paul Scharre, Loren DeJonge Schulman, ​Neil Bhatiya, Ashley Feng, Joshua Fitt, Megan Lamberth, Kristine Lee & Ainikki Riikonen

  • Podcast
    • January 24, 2020
    Armed services continuously make procurement reforms

    There has been years of continuous procurement reform for the Defense Department. Tinkering by Congress has rendered procurement into a sort of laboratory. And each of the arm...

    By Susanna V. Blume

  • Video
    • January 23, 2020
    Winning the Next War

    Chinese and Russian capabilities to exploit vulnerabilities in America's current way of war have grown. Without major changes to how it fights its wars, does the United States...

    By Robert O. Work & Chris Dougherty

View All Reports View All Articles & Multimedia