Cooperative Studies Program Coordinating Center (CSPCC), VA Maryland Health Care System
The Cooperative Studies Program Coordinating Center (CSPCC) is situated in three buildings (Buildings 4, 362T and 363T) in the VA Medical Center at Perry Point, Maryland. Building 4 contains offices, a conference room (equipped with tele-conferencing and phone-conferencing utilities), a printer section equipped with state-of-the-art printing facilities, and other related facilities such as, binders and other items capable of producing three-part Case Report Forms, variable reference guides, protocols and operations manuals for distribution to all study related personnel. A file-room contains data from all past and current clinical trials managed by this center in hard copy format. The second floor houses the entire IT section with all central computer/storage/back-up equipment along with office areas for Statistical Programmers Group and some Database Management staff. The third floor houses the rest of the Database Management group.
Building 362T houses the Center Director, Assistant Directors of Scientific Management and Administration, along with administrative support staff, such as project managers and support clerks. Building 363T houses the administrative support group who handles the VA-NIDA interagency agreement to manage their trials from data and statistical support point of views. Every staff member's office or office area is equipped with a personal computer and a laser printer. In addition, Building 4 has two general-purpose copy machines, a networked color printer, and a large poster printer. Buildings 362T and 363T also have their own general-purpose copy machines and a fax machine.
The CSPCC is connected with the VA-wide computer network via the VA Maryland Health Care System's network. The CSPCC is also a part of the Department of Epidemiology and Preventive Medicine (or DEPM) at the University of Maryland School of Medicine. The PhD biostatisticians of this center hold a faculty affiliation with the University of Maryland. Currently, the CSPCC is participating as a data and statistical center in multiple multi-site randomized clinical trials run by DEPM faculty.
The CSPCC Systems Operations consists of a Dell PowerEdge 4200 Server, serving as the File/Print Server with NetWare 5 as the Network Operating System (NOS). There are future plans to upgrade to a Compaq Proliant DL380 G2 with NetWare 6.5 NOS. Clinical data are securely stored and edited on an Alpha 4100 Server, using the OpenVMS 7.2 operating system, with three 600MHz processors, 2GB memory, and a disk capacity of approximately 130GB. A Dell Precision 410 w/Microsoft NT Server Enterprise Edition will serve as an application server for the FileMaker Pro database used for the CSPCC Address Database, publications, regulatory processes (including training), site information, and study information and tracking IRB information. With a CD Tower attached, this server will also provide administrators and privileged users availability of a 7-bay CD tower for installs, additional clip art, etc. Two Dell PowerEdge 4300's (1 developmental, 1 active) w/Microsoft NT Server Enterprise Edition and IIS functions as the Web Server, allowing study clients secured access to clinical trial databases, thereby bypassing extraneous routing sessions. Available networked printers include three line printers, nine monochrome laser, two color laser, one color poster, and one high-speed color copier/printer. Backup equipment consists of a Compaq Proliant DL320, Dell PowerVault 120-7 cartridge system, Compaq DLT891 - 10-cartridge library system, tabletop 9-track, and a DVD-RW. Computer Associates BrightStor ArcServe and OpenVMS Backup Utility serves as the backup applications.
The infrastructure consists of Category 5 cabling, including several Cisco switches and a PIX Firewall. Staff workstations are configured with Dell Precision, Dimension, and Optiplex personal computers with Windows2000 OS, Hansol/Compaq Flat LCD Monitors, CD-ROM, Internal/External CD/RW, Internal/External Zip Drives, Seiko Label Makers, and APC Back-UPS units. Several Dell Latitude laptop units are available for staff to use when traveling, as well as two LCD Projectors for presentation use. Two ScanJet flatbed scanners are available for staff use on standalone personal computers located in common areas. All servers and personal computers are protected by McAfee's VirusScan anti-virus software. Virus Definitions are configured to provide automatic updates. All components are configured to scan all in-bound and out-bound files.
CDC, Foodborne and Diarheal Disease Branch
The Foodborne and Diarrheal Diseases Branch is an innovative public health investigative and consultative group that identifies causes, sources and solutions for bacterial foodborne and diarrheal infections to prevent the disability and death those diseases cause. Their central values are scientific integrity, rapid response to emergencies, service to states and nations, innovation through informed expertise, and close collaboration between disciplines of epidemiology and microbiology. They are 120 persons organized in three teams: epidemiology teams for foodborne and for diarrheal diseases, and a laboratory team.
The bacterial enteric laboratory at the CDC that handles Shigella also serves as the WHO International Reference Laboratory for Shigella. This well equipped laboratory has expertise for both classical serotyping activities and molecular analysis of Shigella isolates. The professional and technical staff of this reference center is among the most experienced in the world in serotyping Shigella.
CDC's Viral Gastroenteritis Unit, which serves as the WHO/PAHO International Reference Center for Rotaviruses and Other Viral Agents of Gastroenteritis, is just moving to the penthouse of a brand new building at CDC with state of the art equipment. This Unit has developed new diagnostic methods, discovered new viruses, and conducted extensive studies of the viral agents of gastroenteritis in a wide variety of settings, in particular in the developing world. Facilities include walk-in freezers, refrigerators, and incubators, separate P3 facilities for working with potentially pathogenic fecal specimens, isolation rooms for tissue culture, PCR and sequencing. There is a special corridor for storage of specimens and a freezer room with Nitrogen storage for special specimens and reagents. Through CDC, the Unit has the ability to send and receive specimens from around the world and to send reagents out to collaborating laboratories.
Over the past 20 years the Unit has established collaborations with researchers in more than 45 countries. Since the Unit has active collaborations in more than 30 countries for rotavirus surveillance, it is familiar with extensive international activities. As a WHO reference center, the Unit has space and arrangements to train investigators from overseas in new diagnostic methods. The Unit has trained laboratory scientists from more than 35 countries in the recent past to form a global network of collaborators.
International Vaccine Institute, Seoul, Korea
The Republic of Korea was selected in 1994 by the United Nations Development Program (UNDP) as the host country for the International Vaccine Institute (IVI). Since 1997 IVI has functioned as an autonomous, non-profit, international organization under the Vienna Convention. The Institute was established on the premise that infectious diseases continue - and will continue for the foreseeable future - to be the most important cause of deaths in developing countries. The IVI is devoted to bringing new vaccines to the poor populations of the developing world. Its mission is to conduct research and to provide technical assistance and training to accelerate the rational introduction of existing and future new generation vaccines into public health programs of developing countries.
IVI has developed downstream programs of research to provide "translational evidence" needed for rational introduction of new vaccines - integrated, multidisciplinary research programs designed to provide evidence on disease burden, vaccine acceptability, programmatic feasibility, practical vaccine impact on disease, vaccine and illness costs and vaccine cost-effectiveness, and policy options for vaccine introduction. Its current translational research programs address new vaccines against rotavirus diarrhea, cholera, shigellosis, typhoid fever, Hib, pneumococcal disease, Japanese encephalitis, and dengue fever. The programs are being conducted in Bangladesh, Brazil, Cambodia, China, Egypt, El Salvador, India, Indonesia, Korea, Laos, Malaysia, Mongolia, Mozambique, Nicaragua, Pakistan, Panama, Sri Lanka, Thailand, Venezuela and Vietnam.
To conduct these projects, the IVI has a cadre of experienced field epidemiologists and clinical trials specialists with developing country experience in Africa, Asia and Latin America. The Division of Translational Research at IVI houses more than 20 epidemiologists, data managers, statisticians, economists and socio-behavioral specialists responsible for developing packages of evidence at country and regional level for diarrhoeal diseases, JE, dengue and encapsulated respiratory bacteria. The IVI has a long track record of working relationships with NICED in Calcutta where it has conducted complex, multidisciplinary programs in epidemiology, clinical trials, economics, socio-behavioral and policy research in typhoid fever and cholera.
CVD-Chile and University of Chile, Santiago, Chile
Since 1978, the Center for Vaccine Development (CVD) of the University of Maryland has worked continuously in Santiago, Chile with the Chilean Ministry of Health, Chilean universities and other local institutions, in studying infectious diseases of public health importance with the ultimate goal of achieving control through vaccination. In 1991, the field unit was institutionalized as the Centro para Vacunas en Desarrollo, Chile (CVD-Chile) through formal agreements both at the national level (with the Ministry of Health and the Ministry of Justice) and at the Health Service (Servicio de Salud) level with the University of Maryland, Baltimore. The Servicio de Salud Metropolitano Norte (SSMN) is the government Health Service responsible for providing health care in Area Norte (the Northern administrative unit of the Metropolitan Region), which has a total population of 620,000 and an annual birth cohort of 12,000. CVD-Chile serves as a vaccinology and disease control research arm of that Health Service. As part of this long-term intimate collaboration, the SSMN provides CVD-Chile with extensive office and laboratory space in the Roberto del Rio Children's Hospital.
Under the direction of Rosanna Lagos, M.D., Coordinator of CVD-Chile, the unit has assembled an exceptional team of epidemiologists, clinicians, microbiologists, public health nurses and support staff. Over the years, hallmark studies of the epidemiology of Shigella, ETEC, EPEC, EHEC and EAggEC diarrheal pathogens with strong laboratory back-up have been carried out by CVD-Chile.
CVD-Chile collaborates closely with the Institute of Public Health on molecular epidemiologic analyses of isolates of various pathogens. For two decades, CVD-Chile has collaborated closely with the well-equipped Microbiology and Mycology Program of the University of Chile, directed by Professor Valeria Prado in studies of diarrheal disease burden and etiology. A great strength of the Microbiology and Mycology Program of the Faculty of Medicine of the University of Chile is the multi-disciplinary nature of its faculty members. Directed by Professor Valeria Prado, the Program includes medical microbiologists, infectious disease specialists, bacteriologists, virologists, biologists, biochemists, myclogists and veterinarians.
The Enteropathogen Laboratory Group, also headed by Professor Valeria Prado, resides within the Microbiology and Mycology Program and has as a fundamental goal intensive investigations of the clinical epidemiology and molecular epidemiology of bacterial and viral enteropathogens that cause intestinal infections. The emphasis is on diarrheagenic Escherichia coli, Shigella, Salmonella and viral agents including rotavirus and calicivirus. Multiple fully equipped, recently renovated, modern laboratories are available to support the project work-scope.
These laboratories are fully equipped to perform multiplex PCR, ELISA, RT-PCR, and classical diagnostic enteric microbiology (e.g., for Shigella, Salmonella and Campylobacter jejuni). The Enteropathogen Laboratory Group routinely serotypes Shigella using highly specific monoclonal antibodies. With its long history of performing very large epidemiologic studies using both classical microbiologic and molecular diagnostic techniques, the Enteropathogen Laboratory Group of the Faculty of Medicine, University of Chile is well poised to undertake the proposed work-scope.
University of Virginia School of Medicine, Charlottesville, VA, USA
A 900 sq ft BSL-2 laboratory at the University of Virginia is committed to the project, and is adjacent to Dr. Petri's laboratories and office. There is also a 100 sq. ft. cold room and administrative support offices adjacent to the Laboratory. In addition to numerous personal computers available for word processing and data analysis and storage, the computer facilities of the University of Virginia are available via Ethernet. Glassware washing, autoclave, storage, radiation work areas and tissue culture facilities are on-site at the University of Virginia. Core facilities available at the University of Virginia (within a 5 minute walk from the Lab) include protein/nucleic acid sequencing and synthesis centers and hybridoma production and culture center, and FACS center. The Laboratory at the University of Virginia is equipped with two real-time PCR machines, ELISA plate readers, Beckman GPR centrifuge, microfuge, UN/Visible spectrophotometer, gel electrophoresis equipment, peristaltic pump and fraction collector as well as a Dynatech ML-3000 luminescence plate reader.
The Department of Medical Microbiology & Immunology (DMMI), Göteborg University, Goteborg, Sweden
The Department of Medical Microbiology & Immunology (DMMI), Göteborg University, has been collaborating with institutions in developing countries since 1975, in partnership with health authorities, academic institutions and international agencies. This has included epidemiological studies of enteric pathogens and/or Phase I-III studies of enteric vaccines in Asia (e.g., Bangladesh, India, Indonesia), Latin America (Argentina, Peru, Mexico, Guatemala etc) and Africa (Egypt, Mozambique).
The research at DMMI has focused on development of vaccines for cholera, ETEC, Helicobacter pylori and different genital infections with a specific focus on the use of such vaccines in developing countries. This has included as an important component development of methods for identification of several of these pathogens, in particular ETEC (including their virulence factors) as a basis for the composition of new vaccines and methods to assess mucosal immune responses against the different pathogens and key protective antigens.
DMMI has been invited to serve as a WHO reference laboratory for ETEC diagnostics by the World Health Organization. Against this background modern phenotypic (monoclonal antibody based ELISA and dot blot methods) as well as genotypic methods (PCR, multiplex-PCR and DNA-DNA hybridization methods) have been established and standardized and reagents, reference strains, and method manuals for identification of ETEC and their toxins and colonization factors are available at DMMI. The laboratory has also more than 10 years experience in quality control analyses of ETEC strains collected in epidemiological and vaccine studies by collaborative partners and other researchers, e.g., in the United States, Egypt, Bangladesh, Guatemala, Indonesia and Thailand.