First Phase I Study Proves Safety, Immune Response of Ebola DNA VaccineA Phase I trial conducted on an Ebola vaccine candidate developed by the National Institute of Allergy and Infectious Diseases (NIAID) and administered using proprietary DNA delivery technology from Vical Inc. (San Diego, CA, www.vical.com) has shown the vaccine to be safe, well tolerated, and capable of producing both antibody and T-cell Ebola-specific responses in humans.
The DNA vaccine incorporates genetic material encoding core and surface proteins from two strains of Ebola. The vaccine used in the Phase I trial included three bacterial plasmids (pDNAs), one each encoding the surface glycoprotein (GP) from the Zaire strain of Ebola, GP from the Sudan/Gulu strain, and the internal nucleoprotein (NP) from the Zaire strain.
According to Vical, plasmids can be manufactured using "uniform methods" of fermentation and processing. The company secured a nonexclusive license from the National Institute of Health (NIH) to proprietary gene sequences used in the vaccine.
Conducted at the NIH Clinical Center, the Phase I study was the first human trial for any Ebola vaccine. "The high rates of immune responses at all dose levels in this initial human Ebola vaccine study support continued development of this vaccine and further evaluation of our technology for potential additional biodefense and emerging disease applications," said David C. Kaslow, MD, Vical's Chief Scientific Officer, in a company statement. "Our processes allow rapid development and manufacturing of vaccines without handling potentially dangerous pathogens."
