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

IGF::OT::IGF 支持 HPV16L1/RG1 嵌合病毒样颗粒疫苗临床开发任务 1

• 批准号: 9251710
• 负责人: ALEXANDER LYUBIMOV
• 金额: $ 57.79万
• 依托单位: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-25 至 2018-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9251710
• 关键词: Address; Animals; Antibodies; Antibody Response; Award; Biological Assay; Cervarix; Cervical; Clinical; Consultations; Contractor; Contracts; Cutaneous; Development; Dose; Enzyme-Linked Immunosorbent Assay; Epitopes; Genital system; High-Risk Cancer; Home environment; Human; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papillomavirus 16; Human papillomavirus 6; Immunization; In Vitro; Laboratories; Malignant Neoplasms; Marketing; Measures; Medical; Monitor; Mus; Oryctolagus cuniculus; Phase; Phase I Clinical Trials; Preclinical Drug Development; Protocols documentation; Publishing; Reagent; Reporter; Reporting; Safety; Sampling; Schedule; Serum; Surface; Technology; Testing; Universities; Vaccination; Vaccines; Vagina; Validation; Virus Diseases; Virus-like particle; Work; aluminum sulfate; assay development; base; cancer risk; design; immunogenic; immunogenicity; operation; pre-clinical; preclinical safety; preclinical study; programs; research clinical testing; stability testing; synthetic peptide; trial design; vaccine development; vaccine effectiveness; volunteer

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).

背景资料：目前市售的HPV疫苗可防止高达90%的宫颈/粘膜癌相关病毒类型的感染（Guardasil 9）。 为了扩大对所有HPV类型的保护，约翰霍普金斯大学的Richard罗登博士和维也纳医科大学的Reinhard Kirnbauer博士设计了一种嵌合的HP 16 L1病毒样颗粒，该颗粒在VLP表面上展示高度保守的L2免疫原性表位。临床前研究支持这种疫苗对大量HPV类型的有效性。 NCI预防癌症临床前药物开发计划目前正在生产临床级HPV 16 L1/RG 1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期试验将涉及三次疫苗接种（0、2和6个月），并通过三个剂量水平（20、40和80 µg）进行剂量递增。