Development of the Sm14/GLA-SE Schistosomiasis Vaccine Candidate: An Open, Non-Placebo-Controlled, Standardized-Dose Immunization Phase Ib Clinical Trial Targeting Healthy Young Women.

We report the successful closure of Phase I clinical trials, comprising Phases Ia and Ib, of the vaccine candidate against human schistosomiasis: the Schistosoma mansoni 14 kDa fatty acid-binding protein (Sm14) + glucopyranosyl lipid A in squalene emulsion (GLA-SE). Shown here are the results of Phase Ib, an open, non-placebo-controlled, standardized-dose immunization trial involving 10 healthy 18-49-year-old women. Fifty micrograms of the Sm14 protein plus 10 µg GLA-SE per dose was given intramuscularly thrice at 30-day intervals. Participants were assessed clinically, biochemically, and immunologically for up to 120 days. In preambular experiments involving vaccinated pregnant female rabbits, we did not find any toxicological features in either the offspring or mothers, and the vaccine induced adaptive immunity in the animals. In women, no adverse events were observed, and vaccination induced high titers of anti-Sm14 serum IgG antibody production. Vaccination also elicited robust cytokine responses, with increased TNFα, IFNγ, and IL-2 profiles in all vaccinees on days 90 and 120. The completion of Phase I clinical trials, which were performed to the highest standards set by Good Clinical Research Practice (GCP) standards, and preclinical data in pregnant rabbits enabled the vaccine candidate to proceed to Phase II clinical trials in endemic areas.

[Evaluation of small intestine and mesenteric lymph nodes of dogs (Canis familiaris) experimentally infected by Sarcocystis cruzi (Hasselman, 1923) Wenyon, 1926 (Apicomplexa: Sarcocystidae)]. / Avaliação do intestino delgado e linfonodos mesentéricos de cães (Canis familiaris) infectados experimentalmente com Sarcocystis cruzi (Hasselman, 1923) Wenyon, 1926 (Apicomplexa: Sarcocystidae).

Species of the genus Sarcocystis are considered as important parasites of domestic animals. Dogs are considered as definitive host for a variety species of Sarcocystis, when they fed on intermediated host tissues cysts shed sporocysts in their feces. Grinded bovine cardiac muscles, positive for Sarcocystis cruzi was given to two puppies free of coccidia. Both animals shed sporocysts in their feces at 12 days after infection (DAI). These sporocysts measured 17.44 +/- 0.82 11.60 +/- 0.66 mum with shape index of 1.50 +/- 0.05. At 23 DAI, these animals were posted and samples of the small intestine, such as: duodenum, jejune, ileum and mesenteric lymph nodes were collected. In the analysis of small intestine, sporocysts were observed under de mucosa and they were characterized by sporulated sporocysts with sporozoites. Lesions were consisted of discrete edema and plasmocytic cells infiltrations which they were associated to a minimal inflammatory reaction in the presence of parasitic stages. On the other hand, sporocysts were observed at the cortical region near of lymphatic vessels adjacent to mesenteric lymph nodes capsule. It indicated the involvement of the lymphatic vessels in the sporocysts dispersion in the dog mesenteric lymph nodes.