Phase I and II Clinical Trial Comparing the LBSap, Leishmune^®, and Leish-Tec^® Vaccines against Canine Visceral Leishmaniasis.

ABSTRACT: In this study, we performed a phase I and II clinical trial in dogs to evaluate the toxicity and immunogenicity of LBSap-vaccine prototype, in comparison to Leishmune^® and Leish-Tec^® vaccines. Twenty-eight dogs were classified in four groups: (i) control group received 1 mL of sterile 0.9% saline solution; (ii) LBSap group received 600 μg of Leishmania braziliensis promastigotes protein and 1 mg of saponin adjuvant; (iii) Leishmune^®; and (iv) Leish-Tec^®. The safety and toxicity of the vaccines were measured before and after three immunizations by clinical, biochemical, and hematological parameters. The clinical examinations revealed that some dogs of LBSap and Leishmune^® groups presented changes at the site of vaccination inocul

SUBMITTER: Aguiar-Soares RDO 

PROVIDER: S-EPMC7712644 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature