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 10 super(5),10 super(7) or 10 super(9) cfu/ml or SQ at 10 super(2), 10 super(3),10 super(4) or 10 super(5) cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 10 super(7) SCAR and 10 super(9) SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 10 super(5) SCAR, 10 super(7) SCAR 10 super(9) SCAR and 10 super(5) SQ elicited a significantly higher interferon- gamma response frequency.