REPOSITORY SERVICES FOR THE MATERNAL AND PEDIATRIC INFECTIOUS DISEASE BRANCH (MPIDB) SPECIMENS

孕产妇和儿科传染病分支 (MPIDB) 样本库服务

• 批准号: 10838345
• 负责人: OGUZ MANDACI
• 金额: $ 47.48万
• 依托单位: FISHER BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-14 至 2024-05-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10838345
• 关键词: Adolescent; Adolescent Medicine Trials Network; Bar Codes; Biological Specimen Banks; Brazil; Child; Childhood; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; Collaborations; Communicable Diseases; Contractor; Contracts; Data; Data Coordinating Center; Dose; Drug Kinetics; Electronic Mail; Equipment and supply inventories; Exercise; Foundations; Funding; Guidelines; HIV; HIV Infections; HIV therapy; HIV-exposed uninfected infant; HIV/AIDS; Infant; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Label; Laboratories; Management Information Systems; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Notification; Performance; Policies; Population; Pregnant Women; Procedures; Process; Protocols documentation; Public Health Schools; Research; Research Activity; Safety; Sampling; Science; Services; Shipping; Site; Specimen; Symptoms; System; Technology; Teleconferences; Telephone; Toxic effect; United States; United States National Institutes of Health; Update; Vertical Disease Transmission; Woman; Youth; antiretroviral therapy; clinical research site; data management; frontier; operation; pediatric human immunodeficiency virus; perinatal HIV; pregnant; preventive intervention; programs; repository; sample collection; young woman

The Maternal and Pediatric Infectious Disease Branch (MPIDB) promotes research to investigate the impact and treatment of HIV, its complications, and other significant infectious diseases in infants, children, adolescents, and pregnant and nonpregnant women. This includes contracted clinical research activities conducted primarily in two major networks that actively collect specimens to be housed in the NICHD repository. These are the Pediatric HIV AIDS Cohort Study (PHACS) and the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network. PHACS is a multicenter United States-based program that follows both perinatally HIV-infected youth and HIV-exposed/uninfected infants, children, and youth. PHACS currently includes four main protocols and four sub studies. A wide variety of specimen types are collected at 18 SMARTT (Surveillance Monitoring for ART Toxicities Study in HIV-uninfected Children Born to HIV-infected Women) and 14 AMP (Adolescent Master Protocol) current study sites that require repository services. The IMPAACT Network is focused on evaluating potential therapies for HIV infection and its related symptoms in infants, children, adolescents, and pregnant women, including clinical trials of HIV/AIDS interventions for prevention of mother-to-child transmission. The research agenda includes studies on the pharmacokinetics, safety, optimal dosing, and long-term complications of new antiretroviral (ARV) therapies for HIV/AIDS in pediatric and adolescent populations and in pregnant women. NICHD-funded sites (via the NICHD International and Domestic Pediatric and Maternal HIV Studies and Other Infectious Diseases Data Coordinating Center contract) utilize the NICHD repository; NIAID-funded sites utilize a separate NIAID-supported repository. NICHD-supported sites also perform other trials independently or within other networks. The IMPAACT network collects samples in specific protocols at 14 U.S. and 9 international NICHD clinical research sites. A wide variety of specimen types are collected and require repository services. The Data and Operations Center for both PHACS and IMPAACT is at the Harvard School of Public Health with data management services provided by Frontier Science Technology Research Foundation (FSTRF). Both PHACS and IMPAACT use the Frontier Science LDMS laboratory information management system to manage their sample collections. The IMPAACT Network collaborates with the NICHD Domestic & International Pediatric & Maternal HIV & Other High-Priority Infectious Diseases Clinical Studies Network, the Adolescent Medicine Trials Network for HIV/AIDS Interventions, and with other NICHD-, NIH-, and organization-led HIV/AIDS research networks and projects.

母婴传染病分支（MPIDB）促进研究，以调查艾滋病毒及其并发症的影响和治疗，以及婴儿，儿童，青少年，孕妇和非孕妇的其他重大传染病。这包括主要在两个主要网络中开展的合同临床研究活动，这些网络积极收集标本，存放在NICHD储存库中。这两个网络是儿童艾滋病毒/艾滋病队列研究（PHACS）和国际孕产妇、儿童和青少年艾滋病临床试验（IMPAACT）网络。 PHACS是一个多中心的美国为基础的计划，以下围产期艾滋病毒感染的青年和艾滋病毒暴露/未感染的婴儿，儿童和青年。PHACS目前包括四个主要方案和四个子研究。在18个SMARTT（艾滋病毒感染妇女所生未感染艾滋病毒儿童的ART毒性研究监测）和14个AMP（青少年主方案）当前需要储存服务的研究中心收集了各种标本类型。 IMPAACT网络的重点是评估婴儿、儿童、青少年和孕妇艾滋病毒感染及其相关症状的潜在疗法，包括预防母婴传播的艾滋病毒/艾滋病干预措施的临床试验。研究议程包括对儿童和青少年人群以及孕妇中艾滋病毒/艾滋病新抗逆转录病毒（ARV）疗法的药代动力学、安全性、最佳剂量和长期并发症的研究。NICHD资助的研究中心（通过NICHD国际和国内儿科和孕产妇艾滋病毒研究及其他传染病数据协调中心合同）使用NICHD储存库; NIAID资助的研究中心使用独立的NIAID支持的储存库。NICHD支持的研究中心还独立或在其他网络内进行其他试验。 IMPAACT网络在14个美国和9个国际NICHD临床研究中心收集特定方案的样本。收集了各种各样的标本类型，需要储存库服务。 PHACS和IMPAACT的数据和操作中心位于哈佛公共卫生学院，由前沿科学技术研究基金会（FSTRF）提供数据管理服务。PHACS和IMPAACT都使用Frontier Science LDMS实验室信息管理系统来管理其样本采集。 IMPAACT网络与NICHD国内和国际儿科和孕产妇艾滋病毒及其他高优先级传染病临床研究网络，艾滋病毒/艾滋病干预青少年医学试验网络以及其他NICHD，NIH和组织领导的艾滋病毒/艾滋病研究网络和项目合作。