SUPPORT FOR HPV16L1/RG1 CHIMERIC VIRUS-LIKE PARTICLE VACCINE CLINICAL DEVELOPMENT TASKS 1&2

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Background: Currently marketed HPV vaccines protect against infection by virus types associated with up to 90% of cervical/mucosal cancers (Guardasil 9). To potentially expand protection to all HPV types, Drs. Richard Roden, of Johns Hopkins University, and Reinhard Kirnbauer, of the Medical University of Vienna, have designed a chimeric HP16 L1 virus like particle that displays a highly conserved, immunogenic epitope of L2 on the surface of the VLP. Preclinical studies support the effectiveness of this vaccine against a large number of HPV types. The NCI PREVENT Cancer Preclinical Drug Development Program is currently producing clinical grade HPV16L1/RG1 chimeric VLP vaccine for non-clinical safety and Phase I and Phase II, proof of concept testing. The product will be adjuvanted with alum/MPL and thus very similar to Cervarix. While the details of the clinical testing plan are still under development, it is anticipated that the Phase I testing will involve three vaccinations (at 0, 2 and 6 months) with dose-escalation through three dose-levels (20, 40, and 80 µg).