Nonclinical Development of an Improved Polio Vaccine

改良脊髓灰质炎疫苗的非临床开发

• 批准号: 10651872
• 负责人: GREGORY John TOBIN
• 金额: $ 97.65万
• 依托单位: BIOLOGICAL MIMETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10651872
• 关键词: Amino Acids; Animal Model; Animals; Attenuated; Body mass index; Cells; Clinical Trials; Consumption; Containment; Contractor; Contracts; Coupled; Data; Development; Dose; Engineering; Ensure; Environment; Epitopes; Formalin; Formulation; Freezing; Funding; Future; Generations; Goals; Human; Human Resources; Immunization; Immunize; Inactivated Vaccines; Incubated; Injections; Licensing; Methods; National Institute of Allergy and Infectious Disease; Oral Poliovirus Vaccine; Outcome; Output; Pathogenicity; Phase; Phase I Clinical Trials; Phenotype; Poliomyelitis; Poliovirus Vaccines; Population; Price; Process; Production; Rattus; Reaction; Recommendation; Reporting; Reproducibility; Resistance; Running; Safety; Series; Serum; Small Business Innovation Research Grant; Talents; Technology; Technology Transfer; Testing; Toxicology; Update; Vaccination; Vaccines; Virus; Well in self; Wistar Rats; biosecurity; cost; experience; immunogenicity; improved; interest; irradiation; manufacture; manufacturing facility; manufacturing organization; manufacturing process; manufacturing scale-up; meetings; member; method development; milligram; novel; novel vaccines; pathogen; recruit; safety assessment; safety study; vaccine candidate

Abstract In an SBIR Phase II, we developed an improved polio vaccine candidate, primarily for use in the post-eradication era. We call the candidate, ultraIPVTM, because it is produced using a UVC- inactivation method. UltraIPVTM has major improvements compared to existing IPV products, such as IPOL (Sanofi) and VeroPol (Staten Serum Institute). The ultraIPVTM technology is compatible with attenuated virus strains which reduce biosafety and biosecurity concerns during manufacturing. The method is rapid and simple; only 30 seconds of UVC exposure is required for inactivation. The UVC-inactivation process causes less amino acid degradation in protective epitopes, which results in more vaccine units per milligram of virus allowing more doses per batch with reduced costs per dose. Finally, the product is stable through multiple freeze-thaw cycles, which bodes well for long-term storage in national stockpiles. In this SBIR Phase IIB, we propose to complete critical non-clinical development activities for the trivalent ultraIPVTM. These activities include manufacturing scale-up, GLP animal studies of safety and immunogenicity, and IND application submission to prepare for clinical trials. We have assembled a team of subject matter experts with the necessary experience to advance ultraIPVTM through the IND process and beyond. For this product, we have several development avenues ready post-IND, including early- stage interest from potential licensees.

摘要 在SBIR第二阶段，我们开发了一种改进的脊髓灰质炎候选疫苗，主要用于 在后根除时代。我们称之为候选人，ultraIPVTM，因为它是使用UVC生产的- 灭活方法UltraIPVTM与现有IPV产品相比有重大改进， 例如IPOL（Sanofi）和VeroPol（Staten Serum Institute）。ultraIPVTM技术是 与减毒病毒株相容，减少了生物安全和生物安保问题， 制造业该方法快速简单，仅需30秒的UVC暴露， 失活紫外线灭活过程导致保护性氨基酸降解较少。 表位，这导致每毫克病毒更多的疫苗单位，允许每批更多的剂量 降低了每剂量的成本。最后，产品在多次冻融循环中保持稳定， 这预示着在国家储备中长期储存的好兆头。在SBIR第IIB阶段，我们建议 完成三价ultraIPVTM的关键非临床开发活动。这些 活动包括生产规模扩大、安全性和免疫原性的GLP动物研究，以及 提交IND申请，为临床试验做准备。我们已经召集了一组 具有通过IND流程推进ultraIPVTM所需经验的问题专家， 超越。对于这个产品，我们有几个开发途径准备后IND，包括早期- 潜在持牌人的阶段兴趣。