Safety Reactogenicity and Immunogenicity of Francisella tularensis Live Vaccine Strain in Humans

摘要

We evaluated the safety, reactogenicity and immunogenicity of escalating doses of a new Francisella tularensis Live Vaccine Strain (LVS) lot by scarification (SCAR) or subcutaneously (SQ) in humans. Subjects (N=10/group) received one dose of LVS via SCAR at 10⁵, 10⁷ or 10⁹ cfu/ml or SQ at 10², 10³, 10⁴ or 10⁵ cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 10⁷SCAR and 10⁹SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 10⁵SCAR, 10⁷SCAR 10⁹SCAR and 10⁵SQ elicited a significantly higher interferon-γ response frequency.