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

支持HPV16L1/RG1嵌合病毒样颗粒疫苗临床开发任务1

基本信息

批准号：
10329653
负责人：
ALEXANDER LYUBIMOV
金额：
$ 2.88万
依托单位：
UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-25 至 2021-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10329653
关键词：
Address Adjuvant Animals Antibodies Antibody Response Award Biological Assay Cervarix Cervical Clinical Consultations Contractor Contracts Cutaneous Development Dose Enzyme-Linked Immunosorbent Assay Epitopes Genital Genitalia High-Risk Cancer Home Human Human Papilloma Virus Vaccine Human Papillomavirus Human papillomavirus 16 Human papillomavirus 6 Immunization Immunize In Vitro Laboratories Malignant Neoplasms Measures Medical Monitor Mucous Membrane Mus Oryctolagus cuniculus Phase Phase I Clinical Trials Preclinical Drug Development Program Development Protocols documentation Publishing Reagent Reporter Reporting Safety Sampling Schedule Serum Surface Technology Testing Universities Vaccination Vaccines Vagina Validation Vial device Virus Diseases Virus-like particle Work aluminum sulfate assay development base cancer risk clinical development design immunogenic immunogenicity operation phase 1 testing pre-clinical preclinical safety preclinical study research clinical testing stability testing synthetic peptide trial design vaccine development vaccine effectiveness vaccine response volunteer

项目摘要

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。