Preclinical Evaluation of a Novel Immunomodulatory Vaccine for Preventing and Treating HSV Infections
预防和治疗 HSV 感染的新型免疫调节疫苗的临床前评价
基本信息
- 批准号:10600886
- 负责人:
- 金额:$ 28.81万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-08-03 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcyclovirAddressAnimalsAntiviral AgentsAttenuatedAxonBiologicalCaviaCenters for Disease Control and Prevention (U.S.)CitiesClinicalClinical ResearchClinical TrialsCollaborationsDiseaseDisease OutbreaksDoseEncephalitisEngineeringExhibitsFamciclovirFemaleFundingFutureGenitalGenitaliaGoalsGood Manufacturing ProcessHealthHerpes Simplex InfectionsHerpes Simplex Virus VaccinesHerpesviridae InfectionsHerpesvirus 1HumanHuman Herpesvirus 2Immune responseImmunizationImmunizeIndividualInfectionIntramuscularInvestigational DrugsInvestigational New Drug ApplicationLaboratoriesLesionLicensingLifeLouisianaMacaca mulattaMeasuresMeningitisMolecular VirologyMusNeurologicNeuronsPersonsPharmaceutical PreparationsPharmacology and ToxicologyPhasePhase I Clinical TrialsPlayPopulationProcessProductionRecordsRegulatory AffairsSafetySexually Transmitted DiseasesSimplexvirusSmall Business Innovation Research GrantSpecific qualifier valueTestingTherapeuticTissuesToxic effectToxicologyUlcerUniversitiesVaccinatedVaccine ProductionVaccinesVaginaViral Load resultVirulentVirusVirus LatencyVirus ReplicationVirus SheddingVisualWorkWorld Health Organizationagedclinical materialfirst-in-humangenital herpesglycoprotein D-herpes simplex virus type 2guinea pig modelimmunoregulationin vivomanufacturemanufacturing processmanufacturing scale-upnovelnovel vaccinespreclinical evaluationpreclinical safetypreclinical studypreventproduct developmentprophylacticsafety studyscale upstandard of caretransmission processunvaccinatedvaccine developmentvaccine efficacyvaccinologyvalacyclovirviral DNA
项目摘要
PROJECT SUMMARY: Herpes Simplex Virus (HSV) infections are common, infecting more than half of the
world’s population. While most cases of genital herpes are caused by HSV type 2 (HSV-2), it is estimated that
more than 150 million people aged 15-49 have genital HSV type 1 (HSV-1) infections. Although several vaccines
have been evaluated for preventing/treating HSV infections, none have received FDA approval. Through an
exclusive license with Louisiana State University, Rational Vaccines is developing a novel immunomodulatory
vaccine engineered not to enter neuronal axons, rendering it incapable of establishing latency within the host.
This vaccine was shown to be safe and effective at protecting female mice and guinea pigs from lethal
intravaginal challenges with virulent HSV-1 and HSV-2. Further, this vaccine prevented HSV from establishing
latency in vaccinated animals, and it induced prolonged immune responses in rhesus macaques. Moreover, the
vaccine also exhibited therapeutic potential in guinea pigs latently infected with HSV-2. During the funding period
of this Fast-Track proposal, Rational Vaccines will complete the studies required to submit an Investigational
New Drug (IND) application to the FDA. In Phase I, process parameters will be developed, pilot batches of the
RVx1001 will be manufactured, and product specifications will be drafted. This material will be used to validate
the vaccine’s efficacy using the guinea pig model. Phase II will include IND-enabling GLP toxicology studies and
scale-up production of the vaccine under current Good Manufacturing Practices (cGMP) to generate clinical trial
material. The successful completion of the proposed work will extend to first-in-human clinical studies (beyond
the scope of this proposal). Funding the development of this vaccine will play a key role in curbing the spread of
HSV-associated conditions.
单纯疱疹病毒(HSV)感染是常见的,感染了一半以上的人。
世界人口。虽然大多数生殖器疱疹病例是由HSV 2型(HSV-2)引起的,但据估计,
超过1.5亿15-49岁的人患有生殖器HSV 1型(HSV-1)感染。虽然有几种疫苗
已经被评估用于预防/治疗HSV感染,没有一个获得FDA批准。通过
与路易斯安那州州立大学的独家许可,理性疫苗正在开发一种新的免疫调节剂,
疫苗被设计成不进入神经元轴突,使其不能在宿主内建立潜伏期。
这种疫苗被证明是安全和有效的,在保护雌性小鼠和豚鼠从致命的
阴道内用毒性HSV-1和HSV-2攻击。此外,该疫苗防止HSV建立
潜伏期,并诱导恒河猴免疫反应延长。而且
疫苗在潜伏感染HSV-2的豚鼠中也显示出治疗潜力。在供资期间
在这一快速通道提案中,理性疫苗将完成提交研究报告所需的研究。
向FDA提交新药(IND)申请。在第一阶段,将开发工艺参数,
将生产RIGHT 1001,并起草产品规格。该材料将用于验证
用豚鼠模型研究疫苗的效力。II期将包括IND使能GLP毒理学研究,
根据现行药品生产质量管理规范(cGMP)扩大疫苗生产规模,以进行临床试验
材料拟议工作的成功完成将扩展到首次人体临床研究(超过
本提案的范围)。资助这种疫苗的开发将在遏制艾滋病传播方面发挥关键作用。
HSV相关疾病。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Edward Gershburg其他文献
Edward Gershburg的其他文献
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{{ item.author }}
{{ truncateString('Edward Gershburg', 18)}}的其他基金
A novel prophylactic and therapeutic vaccine for ocular herpes simplex virus infections
一种针对眼部单纯疱疹病毒感染的新型预防和治疗疫苗
- 批准号:
10482237 - 财政年份:2022
- 资助金额:
$ 28.81万 - 项目类别:
Definition of structural organization and enzymology of the EBV protein kinase.
EBV 蛋白激酶的结构组织和酶学的定义。
- 批准号:
7916959 - 财政年份:2009
- 资助金额:
$ 28.81万 - 项目类别:
Definition of structural organization and enzymology of the EBV protein kinase.
EBV 蛋白激酶的结构组织和酶学的定义。
- 批准号:
7878932 - 财政年份:2009
- 资助金额:
$ 28.81万 - 项目类别:
Definition of structural organization and enzymology of the EBV protein kinase.
EBV 蛋白激酶的结构组织和酶学的定义。
- 批准号:
7636886 - 财政年份:2008
- 资助金额:
$ 28.81万 - 项目类别:
Definition of structural organization and enzymology of the EBV protein kinase.
EBV 蛋白激酶的结构组织和酶学的定义。
- 批准号:
7472146 - 财政年份:2008
- 资助金额:
$ 28.81万 - 项目类别:
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