The investigational product will be dispensed at the direction of an investigator for administration to a study participant enrolled on the clinical trial. Disposal of expired or unused product will be returned to the manufacturer or disposed of according to standard site procedures based on agreement between the manufacturer and the site. 14.1.2 Toxicity In 2014-2016, a Phase I/IIA human clinical trial was performed at 3 sites in the US in 12 subjects with high-risk HPV infection and biopsy-proven CIN1 to study the safety and immunogenicity of PDS0101. Administration of PDS0101 was well tolerated.