1. Safety, reactogenicity and immunogenicity of Francisella tularensis live vaccine strain in humans.
- Author
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El Sahly HM, Atmar RL, Patel SM, Wells JM, Cate T, Ho M, Guo K, Pasetti MF, Lewis DE, Sztein MB, and Keitel WA
- Subjects
- Adolescent, Adult, Antibodies, Bacterial blood, Bacterial Vaccines administration & dosage, Enzyme-Linked Immunosorbent Assay methods, Female, Humans, Immunoglobulin A blood, Immunoglobulin G blood, Immunoglobulin M blood, Injections, Subcutaneous, Interferon-gamma blood, Male, Placebos administration & dosage, Vaccines, Attenuated administration & dosage, Vaccines, Attenuated adverse effects, Vaccines, Attenuated immunology, Young Adult, Bacterial Vaccines adverse effects, Bacterial Vaccines immunology, Francisella tularensis immunology
- Abstract
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(5),10(7) or 10(9)cfu/ml or SQ at 10(2), 10(3),10(4) or 10(5)cfu/ml; 14 subjects received placebo. All doses/routes were well tolerated. When compared to placebo, vaccination with 10(7) SCAR and 10(9) SCAR resulted in significantly higher serologic response frequencies, as measured by ELISA for IgG, IgM, IgA and microagglutination; whereas vaccination with 10(5) SCAR, 10(7) SCAR 10(9) SCAR and 10(5) SQ elicited a significantly higher interferon-gamma response frequency.
- Published
- 2009
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