Phase I trial of a broad-spectrum HPV vaccine candidate

Persistent infection with carcinogenic (high-risk) types of Human Papillomaviruses (HPV) can cause cervical and other anogenital cancers, as well as carcinomas of the oropharynx (5% of all cancers worldwide). Low-risk types are the cause of genital warts (condylomata). Licensed HPV vaccines are highly effective to prevent infection and disease, yet do not cover all clinically relevant HPV types. Thus, cervical screening cannot be abandoned even in vaccinated women. We have generated an experimental single vaccine antigen RG1-VLP that presents a cross- neutralization epitope and extends protection to all high-risk and several low-risk mucosal HPV types. Promising preclinical research data have promoted vaccine production under Current Good Manufacturing Practice (cGMP) and toxicology studies sponsored by the US National Cancer Institute (NCI). This first-in-human clinical study will determine, if the vaccine candidate is safe and induces an immune response in healthy women 18-45 years of age against multiple HPV types. Female volunteers will be administered increasing doses of RG1-VLP, or saline solution alone as a control. Safety is assessed using defined clinical, laboratory, and self-observational monitoring before, during and 12 months after immunizations. Immune responses are assessed by HPV-specific laboratory tests using blood samples. If successful, this study will promote further development of RG1-VLP as a cost-efficient next-generation prophylactic vaccine to prevent cancers caused by HPV infection worldwide.