Abstract

MARTINEZ, Raydel et al. Reactogenicity of the first Trivalent Cuban Human Leptospirosis Vaccine in Phase II Clinical Trials. Vaccimonitor [online]. 2001, vol.10, n.1, pp.1-7. ISSN 1025-028X.

With the objective of evaluating the reactogenicity of the trivalent Cuban human leptospirosis vaccine (vax-SPIRAL) in groups of selected healthy volunteers using several doses randomized and blind clinical controlled trials were carried out.In the study the volunteers were distributed in two randomized groups in order to observe the adverse reactions to the product at several doses (0,25 and 0,5 mL). The adverse reactions evaluated were symptoms and local signs: pain, redness, local infiltration, itch, necrosis and abscess, and general ones: fever, slight fever, headache, lipothymy, nausea, vomits, rash and general malaise. Serious adverse events were not observed after the administration of the vaccine. Slight fever, local mild pain and general malaise were the most frequent in those vaccinated with a dose of 0,5 mL. The majority of the symptoms and signs disappeared by 72 hours. It was concluded that the vaccine is safe and of low reactogenicity in the studied age groups.

Keywords : Leptospirosis; clinical trials; leptospirosis vaccine; adverse reactions; reactogenicity.

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