Syphilis in Pregnancy Study (SIPS): Molecular Diagnostics and Maternal and Infant Immune Response to Infection
妊娠期梅毒研究 (SIPS):分子诊断以及母婴对感染的免疫反应
基本信息
- 批准号:10702053
- 负责人:
- 金额:$ 70.46万
- 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:2023-06-23 至 2028-05-31
- 项目状态:未结题
- 来源:
- 关键词:AccelerationAddressAfricaAftercareAgeAnimalsAntibodiesAntigensAreaBacterial InfectionsBindingBiological AssayBirthBlood specimenCD4 Positive T LymphocytesCameroonChildhoodClinicalCommunicable DiseasesComplementCongenital SyphilisDataDetectionDevelopmentDiagnosisDiagnosticDiagnostic testsDiseaseEnrollmentFetusFlow CytometryFutureGenerationsGenomeGestational AgeGoalsHIVHigh PrevalenceHumoral ImmunitiesImmuneImmune responseImmune systemImmunityImmunoglobulin GImmunoglobulin MImmunology procedureIncomeInfantInfectionIntegration Host FactorsInternationalKineticsKnowledgeLaboratoriesLesionLive BirthLow Birth Weight InfantMaternal antibodyMaternally-Acquired ImmunityMeasuresMediatingMedicalModelingMolecularMolecular BiologyMolecular Diagnostic TestingMolecular ImmunologyNatural HistoryOralOutcomeParticipantPathogenesisPenicillinsPerformancePerinatalPeripheral Blood Mononuclear CellPlacentaPregnancyPregnant WomenPremature BirthPrevalenceProspective, cohort studyProteomicsPublic HealthReactionRecording of previous eventsRoleSamplingSampling StudiesSerologySerumSpecificitySpontaneous abortionSwabSyphilisT cell responseT-LymphocyteTestingTimeTreponema pallidumUmbilical Cord BloodUnited StatesVertical TransmissionVirulence FactorsWomanZambiaadaptive immune responseadverse birth outcomesadverse outcomeantibody diagnosticantigen-specific T cellsbiomarker identificationcase findingco-infectioncohortdesigndiagnostic algorithmfetalfollow-upgenome sequencinggenomic dataimprovedinfection rateinsightmolecular diagnosticsmultidisciplinaryneonatal deathneonatenovelparityplacental transferpregnantpreventreproductiveresponsesample collectionscreeningstillbirthsuccesssyphilis vaccinetransmission processtreatment responsevaccine candidatevaccine developmentvaccine trialwhole genome
项目摘要
Project Summary/Abstract
Syphilis in women is usually a silent infection caused by Treponema pallidum (T. pallidum) that can efficiently
cross the placenta during all stages of pregnancy and infect the fetus. In the absence of timely diagnosis and
treatment, the natural history of infection in pregnancy includes adverse birth outcomes in 80% (spontaneous
abortion, stillbirth, low birthweight, preterm delivery, congenital syphilis, and neonatal death). Our team and
others have documented elevated prevalence of syphilis in pregnancy in Cameroon and Zambia (3-6%) with
high HIV coinfection rates (10-40%). Despite public health efforts, syphilis is the leading preventable cause of
stillbirth globally and available diagnostic testing has critical limitations in pregnant women and infants. The
Syphilis in Pregnancy Study (SIPS): Molecular Diagnostics and Maternal and Infant Immune Response to
Infection brings together an international team of experts in perinatal and pediatric clinical infectious diseases,
syphilis molecular biology and immunology to address priority questions in the STI field about the natural
history of syphilis in pregnancy and vertical transmission. The SIPS team has designed an observational
cohort to enroll and follow 750 well-characterized pregnant women with confirmed syphilis and their exposed
infants as well as 750 pregnant controls in Cameroon and Zambia with follow up and repeated sample
collection through 12 months after delivery. SIPS participants will have pre- and post-treatment blood samples,
cord blood, and placentas collected from women, neonates, and infants to assess immune responses in
addition to oral and lesion swabs for PCR testing to carry out the following aims: Aim 1: Identify clinical and
host factors independently associated with favorable birth outcomes among pregnant women with syphilis;
Aim 2: Characterize the adaptive T. pallidum immune response before and after treatment in pregnant women
and their exposed infants; Aim 3: Evaluate quantitative PCR (qPCR) testing on oral and lesion swabs to detect
T. pallidum and enhance diagnostic testing in pregnancy and neonates. Aim 1 will test the hypothesis that
factors associated with robust maternal immunity will be associated with favorable birth outcomes in
multivariable models with clinical and host factors. Aim 2 will test the hypothesis that a robust adaptive immune
response (humoral immunity and CD4 T cells) will protect against vertical transmission and assess the role of
T. pallidum-specific transplacental maternal antibodies in mediating fetal and infant protection. Aim 3 will test
our hypothesis that newly developed molecular diagnostic testing of easily collected oral swabs will help refine
and improve the diagnosis of syphilis in pregnant women and infants. Our expected outcome is to identify T.
pallidum antigens with a role in dissemination, placental attachment, and vertical transmission. Our long-term
goals are to advance these newly identified antigens as potential vaccine candidates for reproductive age
women and to support syphilis diagnostic testing with highly specific molecular testing and specific antigens
that can discern syphilis stage and treatment response in pregnant women and infants.
项目概要/摘要
女性梅毒通常是由梅毒螺旋体(T. pallidum)引起的无声感染,可有效
在怀孕的各个阶段穿过胎盘并感染胎儿。在没有及时诊断和治疗的情况下
治疗期间,妊娠期感染的自然史包括 80% 的不良分娩结果(自发性
流产、死产、低出生体重、早产、先天性梅毒和新生儿死亡)。我们的团队和
其他人记录了喀麦隆和赞比亚妊娠期梅毒患病率升高(3-6%)
HIV 合并感染率较高(10-40%)。尽管做出了公共卫生努力,梅毒仍然是可预防的主要病因
全球范围内的死产和可用的诊断检测对孕妇和婴儿来说具有严重的局限性。这
妊娠期梅毒研究 (SIPS):分子诊断和母婴免疫反应
Infection汇集了围产期和儿科临床感染性疾病领域的国际专家团队,
梅毒分子生物学和免疫学,以解决性传播感染领域有关自然传播的优先问题
妊娠梅毒史及垂直传播。 SIPS团队设计了一个观察性的
队列招募并跟踪 750 名确诊梅毒孕妇及其接触者
对喀麦隆和赞比亚的婴儿以及 750 名怀孕对照进行跟踪和重复采样
交货后 12 个月内收集。 SIPS 参与者将获得治疗前和治疗后的血液样本,
从妇女、新生儿和婴儿身上收集脐带血和胎盘,以评估免疫反应
除了口腔和病变拭子进行 PCR 检测之外,还可以实现以下目标: 目标 1:识别临床和病变部位
宿主因素与梅毒孕妇的良好分娩结局独立相关;
目标 2:表征孕妇治疗前后的适应性梅毒螺旋体免疫反应
及其暴露的婴儿;目标 3:评估口腔和病变拭子的定量 PCR (qPCR) 检测以检测
梅毒螺旋体并加强妊娠和新生儿的诊断检测。目标 1 将检验以下假设:
与强大的孕产妇免疫力相关的因素将与良好的出生结果相关
具有临床和宿主因素的多变量模型。目标 2 将检验以下假设:强大的适应性免疫
反应(体液免疫和 CD4 T 细胞)将防止垂直传播并评估
梅毒螺旋体特异性经胎盘母体抗体介导胎儿和婴儿保护。目标 3 将进行测试
我们的假设是,新开发的针对容易收集的口腔拭子的分子诊断测试将有助于完善
提高孕妇和婴儿梅毒的诊断率。我们的预期结果是识别 T。
苍白球抗原在传播、胎盘附着和垂直传播中发挥作用。我们的长期
目标是推动这些新发现的抗原成为育龄期潜在的候选疫苗
女性并通过高度特异性的分子检测和特异性抗原支持梅毒诊断检测
可以辨别孕妇和婴儿的梅毒阶段和治疗反应。
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)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Jodie Ann Dionne其他文献
Jodie Ann Dionne的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Jodie Ann Dionne', 18)}}的其他基金
Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)
减少非洲乙型肝炎的垂直传播(REVERT-B 试验)
- 批准号:
10166897 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)
减少非洲乙型肝炎的垂直传播(REVERT-B 试验)
- 批准号:
10612859 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)
减少非洲乙型肝炎的垂直传播(REVERT-B 试验)
- 批准号:
10375537 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
- 批准号:
10219749 - 财政年份:2019
- 资助金额:
$ 70.46万 - 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
- 批准号:
10218997 - 财政年份:2019
- 资助金额:
$ 70.46万 - 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
- 批准号:
10217939 - 财政年份:2019
- 资助金额:
$ 70.46万 - 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
- 批准号:
10371064 - 财政年份:2019
- 资助金额:
$ 70.46万 - 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
- 批准号:
9903482 - 财政年份:2019
- 资助金额:
$ 70.46万 - 项目类别:
A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV
预防艾滋病毒孕妇疟疾和性传播感染的新疗法
- 批准号:
9766109 - 财政年份:2016
- 资助金额:
$ 70.46万 - 项目类别:
A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV
预防艾滋病毒孕妇疟疾和性传播感染的新疗法
- 批准号:
9270984 - 财政年份:2016
- 资助金额:
$ 70.46万 - 项目类别:
相似海外基金
A mixed methods approach to address multi-level barriers to care for migratory men living with HIV in South Africa
采用混合方法解决照顾南非艾滋病毒携带者移民男性的多层次障碍
- 批准号:
10403224 - 财政年份:2022
- 资助金额:
$ 70.46万 - 项目类别:
Using the EPIC model to build transdisciplinary communities of practice that effectively address urban resilience in Africa and Asia
使用 EPIC 模型建立跨学科实践社区,有效解决非洲和亚洲的城市复原力问题
- 批准号:
2103692 - 财政年份:2022
- 资助金额:
$ 70.46万 - 项目类别:
Standard Grant
A mixed methods approach to address multi-level barriers to care for migratory men living with HIV in South Africa
采用混合方法解决照顾南非艾滋病毒携带者移民男性的多层次障碍
- 批准号:
10689689 - 财政年份:2022
- 资助金额:
$ 70.46万 - 项目类别:
Complex intervention to optimise adolescent BMI pre-conception to address the double burden of malnutrition: A RCT in rural and urban South Africa
优化青少年孕前体重指数以解决营养不良的双重负担的复杂干预措施:南非农村和城市的随机对照试验
- 批准号:
MR/V005790/1 - 财政年份:2021
- 资助金额:
$ 70.46万 - 项目类别:
Research Grant
Complex intervention to optimise adolescent BMI pre-conception to address the double burden of malnutrition: A RCT in rural and urban South Africa
优化青少年孕前体重指数以解决营养不良的双重负担的复杂干预措施:南非农村和城市的随机对照试验
- 批准号:
MR/V005790/2 - 财政年份:2021
- 资助金额:
$ 70.46万 - 项目类别:
Research Grant
An implementation science approach to address multi-level barriers to cancer screening among women living with HIV in South Africa
一种实施科学方法,以解决南非艾滋病毒感染妇女癌症筛查的多层次障碍
- 批准号:
10242935 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
解决东非艾滋病毒流行的持续驱动因素的多部门战略
- 批准号:
10267216 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
解决东非艾滋病毒流行的持续驱动因素的多部门战略
- 批准号:
10085144 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa
解决东非艾滋病毒流行的持续驱动因素的多部门战略
- 批准号:
10438844 - 财政年份:2020
- 资助金额:
$ 70.46万 - 项目类别:
Teaching empowerment: Grass-roots educators' strategies to address gender equity in the context of the HIV epidemic in South Africa
教学赋权:基层教育工作者在南非艾滋病毒流行背景下解决性别平等问题的战略
- 批准号:
218055 - 财政年份:2010
- 资助金额:
$ 70.46万 - 项目类别:
Studentship Programs














{{item.name}}会员




