Peer-reviewed veterinary case report
Safety of Leishmune vaccine in 600 healthy Brazilian dogs
By Parra, L E et al.·Published in Vaccine·2007·Fort Dodge Saú, Brazil·View original on PubMed →
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Original publication title: Safety trial using the Leishmune vaccine against canine visceral leishmaniasis in Brazil.
- Species:
- dog
Plain-English summary
A group of 600 healthy dogs in Brazil received the Leishmune vaccine to protect against canine visceral leishmaniasis, a serious disease spread by sandflies. After vaccination, some dogs experienced mild side effects like local pain, loss of appetite, and swelling at the injection site, but these reactions were temporary and mostly resolved before the next dose. Only a few dogs had more noticeable reactions, such as facial swelling or itching, but there were no serious allergic reactions or deaths. Overall, the vaccine was well-tolerated, showing that it can be a safe option for protecting dogs in areas where this disease is common.
People also search for: dog leishmaniasis vaccine · Leishmune side effects · canine vaccine reactions · dog vaccination safety · Brazilian dog health issues
Abstract
A group of 600 healthy and asymptomatic dogs from Brazilian canine visceral leishmaniasis endemic areas was vaccinated with three sc doses of Leishmune which is the industrialized formulation of the FML-saponin, recently licensed for commercialization in Brazil, which previously showed 76-80% vaccine efficacy against canine visceral leishmaniasis. Safety evaluation was performed for 14 days after each vaccine injection and disclosed transient reactions of local pain (40.87%), anorexia (20.48%), apathy (24.17%), local swelling reactions (15.90%), vomit (2.4%) and diarrhoea (1.5%). All effects showed significantly correlating declines, from the first to the third dose (p<0.0001). Most of the noticed reactions of pain (73%), anorexia (79%) and local swelling (84.7%) were mild. No significant differences between puppies and adults dogs were found in the number of adverse reactions. Adult dogs developed however, 94.5% of the small swelling reactions (<3 cm), and indicating that they are more resistant to the inflammatory response promoted by the saponins. No dead by anaphylaxis occurred, and only two dogs (0.1%) showed allergic reactions (facial oedema and itching) after the third dose. Transient alopecia on injection site occurred in only five poodles (0.28%) with total recovery and no need of treatment. All the mild adverse events in response to Leishmune injection were transient and disappeared before the injection of the following vaccine dose, confirming the tolerability of the vaccine. The Leishmune preparation was less haemolytic (HD(50)=180 microg/ml) than expected for a QS21 saponin-containing vaccine, indicating that its formulation with the FML antigen diminished the potential in vitro toxicity.
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Search related cases →Original publication on PubMed: https://pubmed.ncbi.nlm.nih.gov/17239495/