DNA vaccines company Vical is collaborating with researchers at the Virginia Commonwealth University who have received a $4 million NIAID grant to develop a vaccine for preventing CMV infection in women of child-bearing potential. The money will be used to carry out preclinical in vivo testing.
Vical will produce the DNA vaccines, and along with its Vaxfectin® adjuvant, it will carry out the animal studies. Vaxfectin is a cationic lipid formulation optimized to increase the immune response to plasmid DNA vaccines.
Protein-based prophylactic CMV vaccines have traditionally focused on antibody-mediated immune responses against the CMV glycoprotein B (gB) antigen, Vical explains. Such vaccines typically achieve up to 50% protective efficacy and are most effective at preventing CMV infection of human fibroblast cells, the firm adds.
Studies by the VCU researchers have identified additional CMV antigens that may be exploited to prevent CMV infection of human epithelial cells. The collaboration between Vical and VCU researchers, Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., will focus on evaluating vaccine strategies that target the new antigens and combining them with gB-based vaccines.
Vical is using its plasmid DNA delivery technology in house to develop two CMV vaccines: TransVax™ and CyMVectin™. TransVax is designed to prevent CMV reactivation or infection in transplant recipients and is currently in Phase II trials. CyMVectin is a prophylactic vaccine designed to help prevent congenital infection of babies by vaccinating women before pregnancy.
The firm believes that this approach represents a major commercial opportunity and may ultimately lead to universal pediatric vaccination. Vical says FDA has now granted IND approval to start clinical trials with CyMVectin, and the company is currently evaluating the best way to advance development either independently or with a corporate partner.