COVID Protection After Transplant (CPAT) Multicenter Adaptive Trial
移植后新冠肺炎保护 (CPAT) 多中心适应性试验
基本信息
- 批准号:10457200
- 负责人:
- 金额:$ 694.18万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2023-07-31
- 项目状态:已结题
- 来源:
- 关键词:2019-nCoVAcuteAdenovirus VectorAdjuvantAntibodiesAntibody FormationAntibody ResponseAntigensAntimetabolitesAvidityB-Lymphocyte SubsetsBayesian ModelingBiological AssayBiometryCD8-Positive T-LymphocytesCOVID-19COVID-19 mortalityCOVID-19 pandemicCOVID-19 vaccinationCOVID-19 vaccineCellular ImmunityCoupledDataDevelopmentDiabetes MellitusDoseEffectivenessEnrollmentEpitopesEventFlow CytometryFunctional disorderFutilityGeneral PopulationGoalsHeartHumoral ImmunitiesImmune responseImmunityImmunocompetentImmunodominant EpitopesImmunoglobulin Class SwitchingImmunologic MemoryImmunologicsImmunologyImmunophenotypingImmunosuppressionInfectionInfectious Disease EpidemiologyInfrastructureInterventionKidneyKidney TransplantationLibrariesLiverLongitudinal StudiesLungMemory B-LymphocyteMessenger RNAMetabolicMonitorMulti-Institutional Clinical TrialOrganOrgan TransplantationPathologyPatientsPeptidesPersonsPhenotypePilot ProjectsPopulationProbabilityProspective cohortRNA vaccineRandomizedReactionReportingRiskRouteSafetySecondary ImmunizationSeriesSolidSpeedStainsT cell receptor repertoire sequencingT cell responseTechnologyTimeTransplant RecipientsTransplantationTransplantation SurgeryUnited StatesVaccinatedVaccinationVaccine AntigenVaccinesVirusVirus-like particleVulnerable Populationsantigen-specific T cellsarmcomorbiditycoronavirus diseasedata managementdesigndonor-specific antibodyenzyme linked immunospot assayexperiencefollow-upimmunogenicimmunogenicityimmunoregulationimprovedinterestmortalitymultidisciplinarynovelolder patientoperationpilot trialprogramsresponsesafety studysingle-cell RNA sequencingsuccesstransplant centerstreatment armtrial designvaccination strategyvaccine safetyvaccine trialvariants of concernvirology
项目摘要
Solid organ transplant recipients experience high mortality from COVID-19 due to a combination of
immunosuppression and comorbidities. Although SARS-CoV-2 vaccination has been highly effective in the
general population, recent studies show that solid organ transplant recipients are less likely to develop
protective antibody responses. In addition, long term studies of safety, including immunologic sequela such as
rejection, and de novo donor-specific antibody formation are lacking.
We propose a Multicenter Randomized Adaptive Design Trial to investigate strategies for CPAT (COVID
Protection After Transplant). This trial will build on results from a CPAT Pilot Trial in 200 kidney transplant
reipients which will investigate the safety and immunogenicity of 3rd dose of a SARS-CoV-2 mRNA vaccines in
recipients who fail to develop high level antibodies after a standard 2 dose series. That trial will identify key
correlates of risk and efficacy. This trial will incorporate that data to investigate additional protective strategies
including the use of different vaccine platforms and changes in immunosuppression in 800 solid organ
transplant recipients with suboptimal anti-spike antibody responses across 15 US transplant centers. This trial
will personalize randomization to candidate arms with the highest probability of success using a Bayesian
framework. In conjuction, we will perform novel, comprehensive virologic and immunologic mechanistic studies
to better understand vaccine-associated immunity over time.
Our multidisciplinary team includes experts in Transplant Surgery, Infectious Diseases, Epidemiology,
Biostatistics, Pathology, Virology, and Immunology. Our team has experience successfully enrolling and
conducting multicenter transplantation trials (U01AI134591, U01AI138897) and will leverage existing
infrastructure for operations, data management, analysis, and safety reporting.
In summary, this Multicenter Adaptive Design CPAT Trial will determine the immunogenicity and safety of
novel SARS-CoV-2 vaccination strategies in 800 transplant recipients across the United States. Important
mechanistic studies will further fundamental understanding of development of protective immune responses in
this vulnerable population.
实体器官移植患者因新冠肺炎感染死亡率较高,原因是
免疫抑制和合并症。尽管SARS-CoV-2疫苗接种在全球范围内非常有效
普通人群,最近的研究表明,实体器官移植的接受者不太可能发生
保护性抗体反应。此外,长期的安全性研究,包括免疫后遗症,如
缺乏排斥反应和新的供体特异性抗体的形成。
我们提出了一项多中心随机适应性设计试验来研究Cpat(COVID)的策略
移植后的保护)。这项试验将基于CPAT在200例肾移植中的先导试验的结果
将研究第三剂SARS-CoV-2mRNA疫苗在中国的安全性和免疫原性的研究
在标准的2剂剂量系列后未能产生高水平抗体的受者。这场审判将确定关键
风险和疗效的相关性。这项试验将结合这些数据来调查额外的保护策略
包括不同疫苗平台的使用和800固体器官中免疫抑制的变化
在15个美国移植中心,移植受者的抗尖峰抗体反应不佳。这场审判
将使用贝叶斯对具有最高成功概率的候选手臂进行个性化随机化
框架。同时,我们将进行新颖、全面的病毒学和免疫学机制研究。
随着时间的推移,更好地了解疫苗相关免疫。
我们的多学科团队包括移植外科、传染病、流行病学、
生物统计学、病理学、病毒学和免疫学。我们的团队有成功招生和
进行多中心移植试验(U01AI134591、U01AI138897),并将利用现有的
用于运营、数据管理、分析和安全报告的基础设施。
总之,这项多中心适应性设计CPAT试验将确定
在全美800名移植受者中采用新的SARS-CoV-2疫苗接种策略。重要
机制研究将进一步加深对保护性免疫反应发展的基本理解
这些脆弱的人群。
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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Christine Marie Durand其他文献
Christine Marie Durand的其他文献
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{{ truncateString('Christine Marie Durand', 18)}}的其他基金
Kidney Transplantation from Donors with HIV: Impact on Rejection and Long-term Outcomes
艾滋病毒捐献者的肾移植:对排斥和长期结果的影响
- 批准号:
10704333 - 财政年份:2023
- 资助金额:
$ 694.18万 - 项目类别:
A Randomized Controlled Trial of Prophylaxis with Direct-acting Antivirals for Kidney Transplantation from Hepatitis C virus-infected donor to Uninfected Recipients (PREVENT-HCV)
直接作用抗病毒药物预防丙型肝炎病毒感染供者肾移植至未感染受者的随机对照试验 (PREVENT-HCV)
- 批准号:
10597168 - 财政年份:2022
- 资助金额:
$ 694.18万 - 项目类别:
A Randomized Controlled Trial of Prophylaxis with Direct-acting Antivirals for Kidney Transplantation from Hepatitis C virus-infected donor to Uninfected Recipients (PREVENT-HCV)
直接作用抗病毒药物预防丙型肝炎病毒感染供者肾移植至未感染受者的随机对照试验 (PREVENT-HCV)
- 批准号:
10405358 - 财政年份:2022
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10492082 - 财政年份:2021
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A clinical trial of HIV-to-HIV deceased donor kidney transplantation
希望在行动:艾滋病毒转艾滋病毒死者供体肾移植的临床试验
- 批准号:
10462020 - 财政年份:2021
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10214504 - 财政年份:2018
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
9753122 - 财政年份:2018
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10459319 - 财政年份:2018
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10622648 - 财政年份:2018
- 资助金额:
$ 694.18万 - 项目类别:
HOPE in Action: A Clinical Trial of HIV-to-HIV Liver Transplantation
希望在行动:HIV 至 HIV 肝移植的临床试验
- 批准号:
10681594 - 财政年份:2018
- 资助金额:
$ 694.18万 - 项目类别:
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