Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V

Summary

The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.

Timeline

Start

2004-11

Primary completion

2006-07

Completion

2006-09

Drugs

Indications