IGF::OT::IGF SUPPORT FOR HPV16L1/RG1 CHIMERIC VIRUS-LIKE PARTICLE VACCINE CLINICAL DEVELOPMENT TASKS 1&2 PP: 9/25/2015 TO 9/24/2018

背景：目前上市的HPV疫苗可预防与高达90%的宫颈癌/粘膜癌相关的病毒类型感染（Guardasil 9）。为了潜在地扩大对所有HPV类型的保护。约翰霍普金斯大学的Richard Roden和维也纳医科大学的Reinhard Kirnbauer设计了一种嵌合hp16l1病毒样颗粒，该颗粒在VLP表面显示高度保守的L2免疫原性表位。临床前研究支持该疫苗对大量HPV类型的有效性。NCI prevention癌症临床前药物开发项目目前正在生产临床级HPV16L1/RG1嵌合VLP疫苗，用于非临床安全性和I期和II期概念验证测试。该产品将使用明矾/MPL作为佐剂，因此与Cervarix非常相似。虽然临床试验计划的细节仍在开发中，但预计I期试验将包括三种疫苗接种（0、2和6个月），并通过三个剂量水平（20、40和80µg）逐步增加剂量。

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).