A lyophilized formulation of RiVax, a recombinant ricin subunit vaccine, retains immunogenicity

Ricin is a CDC level B biothreat. Our recombinant ricin A chain vaccine (RiVax) contains two mutations, rendering it non-toxic at high doses. Frozen or alum formulations of RiVax protected mice against ricin administered by injection, gavage or aerosol. Without alum, RiVax was safe and immunogenic in rabbits and human volunteers. For military use, the predominant target group, it would be optimal not to require a cold chain for transport and storage. We have now developed a lyophilized formulation and demonstrated stability and efficacy for at least 1 year stored refrigerated or at room temperature administered with or without alum.