This Phase 1 clinical trial is to study dose escalation of RiVax. The study will have 30 participants divided into 3 groups. 5 patients will be in each dose group, then 15 more patients in the "best" group.
3 vaccinations in volunteers, at 0, 6, and 16 weeks.
The final report was submitted to the FDA on September 26, 2012.
Results
Soligenix, Inc. (OTCQB: SNGX), announced August 30, 2012, the results of this clinical trial. The results of the Phase 1B study indicate that Alum adjuvanted RiVax™ is safe and well-tolerated, and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™.