Product optimization to commercialize an oral bacteriophage cocktail that prevents cholera in real-world settings
产品优化,以将可在现实环境中预防霍乱的口服噬菌体混合物商业化
基本信息
- 批准号:10555220
- 负责人:
- 金额:$ 93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-12-15 至 2025-01-31
- 项目状态:未结题
- 来源:
- 关键词:AcuteAdsorptionAdultAdvisory CommitteesAfricaAnimalsAntibiotic ResistanceAntibioticsAsiaBacteriaBacteriophagesBiological AssayChemoprophylaxisCholeraCholera VaccineClimateClinicalClinical TrialsCold ChainsCollectionCommunitiesContractsCountryDependenceDiseaseDisease OutbreaksDoseDrug resistanceEmergency treatmentEnsureEnvironmentEpidemicExcipientsFamilyFormulationFundingFutureGeographic DistributionHealthHouseholdHygieneIn VitroIndividualInfantInfrastructureInterventionInterviewInvestmentsMeasuresMethodsModelingMusOralOral AdministrationOryctolagus cuniculusParticle SizePatientsPersonsPharmaceutical PreparationsPhasePlayPreventionPreventiveProcessProductionProphylactic treatmentQuality ControlRecommendationRefrigerationResistanceResourcesRiskRoleSanitationSchemeServicesSmall Business Innovation Research GrantSmall Business Technology Transfer ResearchSmall IntestinesSolidSourceSymptomsTarget PopulationsTestingTimeVibrio choleraeWaterWorld Health Organizationclinical efficacyclinical trial readinesscommercializationcommunity transmissioncontaminated watercostdiarrheal diseasedosagedysbiosisfirst-in-humanhigh riskhigh risk populationholistic approachimprovedin vivoindexinginfection riskmanufacturemanufacturing processoutbreak controloutbreak responsepreventprotective efficacysuccesssurveillance studytransmission process
项目摘要
Project Summary
Cholera is an acute and severe disease caused by the bacterium Vibrio cholerae that is spread primarily
through contaminated water sources due to a lack of adequate sanitation infrastructure. The World Health
Organization estimates that there are at least 3 million cases globally per year, 40 percent of which are spread
through household transmission. Current prevention methods, such as the oral cholera vaccine (OCV) and water,
sanitation, and hygiene (WASH) campaigns, require significant investment of resources and time for efficacy,
but household contacts of cholera patients often present with cholera symptoms two to three days after the initial
patient becomes sick. In addition, the preventive use of antibiotics is not recommended due to widespread
resistance and the known negative consequences of dysbiosis. There is a pressing need to develop a targeted
clinical intervention to prevent the community spread of cholera using a rapid prophylactic treatment. PhagePro
aims to fill this gap with its first product ProphaLytic-VcTM (PVC). PVC is an orally administered bacteriophage
(phage) cocktail comprised of Vibriophages ICP1, ICP2, and ICP3.
In this Phase II SBIR proposal, we aim to further develop PVC for deployment in real-world settings as part
of a cholera toolkit that includes WASH and OCV campaigns. First, we aim to test co-administration of PVC with
the OCV, particularly as the WHO Global Task Force on Cholera Control (GTFCC) recommends that National
Cholera Control Plans (NCCP) move towards integration of services to reduce logistical burden and costs. In
addition, the majority of interviewed stakeholders stated that a holistic approach is critical to cholera control.
Second, we have identified that cold chain dependence is a major contributor to OCV campaign costs. Therefore,
we aim to build upon our Phase I STTR success to develop PVC in a solid dosage formulation. This will increase
the stability of PVC in hot and humid environments, enabling Ministries of Health to stockpile PVC in-country and
distribute to identified cholera hotspots without the use of the cold chain. This mechanism will increase timeliness
of the cholera outbreak response, which has been identified as the key factor in controlling an outbreak in both
endemic and non-endemic settings. Third, we aim to optimize phage ratios in PVC to most effectively kill
circulating strains of V. cholerae. We will collect 96 clinical isolates from recent epidemics in South Asia and
Africa in the past 3 years to determine host range coverage. Additionally, we will optimize the ratio of phages on
2 representative clinical isolates to best reduce V. cholerae colonization in mice. Lastly, we will establish a post-
exposure, pre-symptomatic rabbit model to better simulate clinical settings for the HCs during the high-risk period
and demonstrate that PVC can effectively prevent the onset of symptoms.
At the successful conclusion of Phase II, we will have a solid dosage formulation of PVC that is effective in
preventing the onset of cholera symptoms in an established household transmission model for cholera. Future
investments and non-dilutive funding will fund clinical surveillance studies, GMP manufacturing for clinical trials,
and a first-in-human trial to demonstrate proof-of-clinical-efficacy.
项目总结
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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Andrew Camilli其他文献
Andrew Camilli的其他文献
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{{ truncateString('Andrew Camilli', 18)}}的其他基金
Targeting antibiotic resistance genes in Vibrio cholerae using a phage-encoded CRISPR-Cas system to improve efficacy of phage prophylaxis
使用噬菌体编码的 CRISPR-Cas 系统靶向霍乱弧菌中的抗生素抗性基因,以提高噬菌体预防的功效
- 批准号:
10320480 - 财政年份:2021
- 资助金额:
$ 93万 - 项目类别:
Product optimization to commercialize an oral bacteriophage cocktail that prevents cholera in real-world settings
产品优化,以将可在现实环境中预防霍乱的口服噬菌体混合物商业化
- 批准号:
10349544 - 财政年份:2018
- 资助金额:
$ 93万 - 项目类别:
Developing a Scalable Manufacturing Process for an Oral Bacteriophage Product that Prevents Cholera
开发预防霍乱的口服噬菌体产品的可扩展制造工艺
- 批准号:
10086723 - 财政年份:2018
- 资助金额:
$ 93万 - 项目类别:
Developing a Scalable Manufacturing Process for an Oral Bacteriophage Product that Prevents Cholera
开发预防霍乱的口服噬菌体产品的可扩展制造工艺
- 批准号:
10097213 - 财政年份:2018
- 资助金额:
$ 93万 - 项目类别:
Developing a novel strategy to uncover vaccine targets in bacterial pathogens
开发一种新策略来发现细菌病原体中的疫苗靶点
- 批准号:
8990816 - 财政年份:2015
- 资助金额:
$ 93万 - 项目类别:
Developing a novel strategy to uncover vaccine targets in bacterial pathogens
开发一种新策略来发现细菌病原体中的疫苗靶点
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8891081 - 财政年份:2015
- 资助金额:
$ 93万 - 项目类别:
Impact of Bacteriophages on Virulence and Transmission of Vibrio cholerae
噬菌体对霍乱弧菌毒力和传播的影响
- 批准号:
10548231 - 财政年份:2003
- 资助金额:
$ 93万 - 项目类别:
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