This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary goal of this clinical trial is to assess the safety and reactogenicity (tolerability) of ascending dosages of LVS among healthy subjects when given in a single dose by one of two different routes: subcutaneous (SC) or percutaneous (scarification). The study is a Phase I, double-blinded, placebo-controlled trial designed to evaluate the safety of a single-dose schedule of three different dosage levels (105-, 107- and 109 cfu /mL) of Francisella tularensis (Ft) LVS administered by scarification. When the safety of LVS administered at 107cfu/mL by scarification is established, the safety of a single-dose schedule of four different dosage levels of LVS (102-, 103-, 104- and 105 cfu/dose) administered SC will be evaluated. Each dosage level will have 10 subjects receiving vaccine and 2 subjects receiving placebo. The evaluation of the lowest vaccine dosage given subcutaneously will begin simultaneously with the evaluation of the highest dosage of the vaccine given by scarification. Secondary endpoints include the determination of several immunogenicity parameters, including humoral, cell mediated and cytokine responses following vaccination.
Showing the most recent 10 out of 459 publications
