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Vaccine and adjuvant Clinical GMP product development and DNA Technology platform enhancements

疫苗和佐剂临床 GMP 产品开发和 DNA 技术平台增强

基本信息

批准号：
10589589
负责人：
Trevor Smith
金额：
$ 118.01万
依托单位：
WISTAR INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-12-08 至 2027-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10589589
关键词：
Adjuvant Advanced Development Animal Model Animals Antigens Asia Cavia Charge Clinical Clinical Research Clinical Trials Collaborations Coupled Cyclic GMP DNA DNA Vaccines Dedications Development Devices Dose Drug Delivery Systems Electroporation Europe Evaluation Goals Guidelines HIV HIV Antigens HIV Vaccine Trials Network HIV vaccine Human Immune response Interleukin-12 International Intramuscular Mediating Modeling Persons Pharmaceutical Preparations Pharmacologic Substance Phase Plasmids Process Production Program Development Protocols documentation Research Research Support Running Skin Technology Vaccines Vial device Work clinically relevant cytokine design experience immunogenicity in vivo manufacture manufacturing facility minimally invasive next generation novel phase 3 study plasmid DNA portability preclinical development preclinical study product development programs promoter research clinical testing scale up synergism synthetic construct technology platform vaccine delivery vaccine development

项目摘要

Project 3 Summary Project 3 is primarily focused on the product production aspects of this IPCAVD proposal (Specific Aim 1). It is directed by a leading HIV vaccine development organization – Inovio Pharmaceuticals (INO) who have advanced multiple clinical DNA vaccine programs. Inovio has extensive expertise in development of synthetic DNA vaccines and advanced in vivo electroporation delivery. The central goal of Project 3 is to cGMP manufacture and deliver product for 2 DNA immunogen constructs in years 4 and 5 of the program. Using Inovio’s advanced process technology the experienced team will manage CMC aspects of producing product with specific state-of- the-art manufacturing facilities for drug substance and drug product activities resulting in vialed doses, and support IND submission to be delivered in year 5 of the program. Additionally, Inovio will support the use of the next generational compact, portable, hand-held intradermal EP delivery device, CELLECTRA™ 3PSP. This device will be provided and employed for the preclinical studies across all animal models throughout this program. 3PSP will be available to support the subsequent clinical trials which will be initiated by the HVTN. In Specific Aim 2 Project 3 will collaborate with Project 1 to evaluate and advance the development of dual antigen and cytokine DNA constructs. Our development work with the dual promoter IL-12 constructs, will provide the blueprint for these dual promoter constructs that will express a HIV antigen and cytokine adjuvant. Project 3 will provide coordination and support of the NHP studies throughout the duration of the project which will include immunogenicity and IND-enabling studies to advance the development HIV vaccine constructs originating from Project 1 and 2. In Specific Aim 3, we will evaluate DNA vaccine delivery employing transformative skin delivery protocols in clinically relevant models, including guinea pigs and NHPs, integrating needleless jet delivery with skin electroporation. In summary, Project 3 will provide high quality concentrated drug product for subsequent HVTN clinical testing and advance the development of novel HIV DNA vaccine constructs and delivery platforms.

项目3总结