HOSPITAL AND COMMUNITY BASED STUDY - VIETNAM

Sources Sought Notice The Naval Medical Logistics Command (NMLC) is seeking sources for research and development support Services in support of Rickettsial Diseases, Scrub Typhus and Q Fever surveillance study. The Government's requirement is for research support from a capable institution with a large trajectory of research in infectious and tropical diseases, mainly in vector borne infections for a collaborative research effort to execute in Vietnam the studies entitled: "Hospital and Community based investigation of Rickettsial Diseases, Scrub Typhus and Q Fever". This study is aimed at determining the presence and prevalence of Rickettsial diseases. This effort requires: - Obtain IRB and Scientific Committee Approval prior to initiation of hospital-based study. - Provide Standard Operating Procedures (SOPs) and training as necessary for rickettsial, oriential and coxiella investigations in order to ensure safe and effective implementation of project activities. - Develop Data Storage Capability, where data collection formats will be used collaboratively between the scientists and the statistician. Data will be collected by trained study staff via standardized electronic case record forms (eCRFs) using tablets and uploaded to a dedicated central serverover 3G or WiFi. - Recruit patients and discuss with hospital management of 3 national hospital and 24 provincial hospitals the proposed project and obtain agreement. Provide project overview to personnel involved in study, to include their roles and tasks. Provide GCP and protocol training for hospital personnel involved in study to include: Administrators, Physicians (identify patients to request their enrollment in study, enroll patients, collect eCRF (i.e. patient history and physical examination), and notify study nurse), Study Nurse (collection of consent forms and completed epidemiologic questionnaire, collection of acute samples (i.e. clotted blood, whole EDTA blood for serologic and molecular assays, respectively) before treatment. - Transport all Samples to BSL-2 Laboratory for Serologic and Molecular Analysis and use a professional transport company to transfer these samples. - Perform ELISA on serum samples (acute samples) (n=2,700-4,100) collected from patients. - Identify evidence of previous infection with spotted fever group rickettsiae (SFGR), typhus group rickettsiae (TGR), scrub typhus group orientiae (STGO) and Coxiella burnetii IgG ELISAs. - Conduct qPCR assays to identify rickettsiae, orientiae, and C. burnetii from DNA extracted from whole blood (EDTA) samples. This will identify active cases of diseases and either genus- or species specific. Use of multilocus sequence typing (MLST) is required if a species-specific qPCR assay is not available to make the agent identification. - Combine patient clinical (history and PE), location (GPS of village), serology, and qPCR information/results. Perform data analysis and summarize clinical, epidemiologic and laboratory data. Calculate prevalence of rickettsial diseases, scrub typhus and Q fever among fever patients admitted to 27 hospitals in 26 provinces throughout Vietnam by molecular methods. In addition, calculate prevalence of antibodies to SFGR, TGR, STGO and C. burnetii among fever patients. The acquired data will be entered into CliRes for subsequent analysis by EpiInfo to determine statistical data analysis of pathogen prevalence. - Generate GIS maps that will be used to create thematic maps of disease prevalence for the 8 ecological regions of Vietnam for each disease and perform GIS analyses. - Identify10 random villages, towns and/or cities (hotspots) per each of 8 agro-ecological regions (80 sites) based on the demographical information yielded from hospital-based study to investigate the risk for rickettsial diseases, scrub typhus and/or Q fever. For each commune 40 households (approximately 4-5 people/house) should be randomly selected for a cross-sectional study to estimate the seroprevalence of rickettsial diseases, scrub typhus, and Q fever. Total number of villagers to be enrolled for the 8-region IRB approved study should be approximately 16,000. - Draft and submit reports to MoH and DTRA and develop presentation(s) for scientific/medical meeting(s) and a manuscript(s) for publication. - All activities must be carried out with the outmost adherence to all ethical and quality standards in order to minimize risk of performance slips and comply with appropriation of funds and expectations of the sponsor. The period of performance is expected to be 12 months from the date of contract approval and three additional Option Periods. If capable sources are not identified through this notice, then NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (One source) to National Hospital of Tropical Diseases (NHTD) in Vietnam, for the performance of the described requirement. National Hospital of Tropical Diseases (NHTD)is the only source able to meet our research needs for Vietnam. NHTD has a large trajectory of treatment and research in infectious and tropical diseases. This institution is the only one with the required local approvals in place, the appropriate financial, human and technical resources, experience and organizational controls needed to accomplish the study's goals. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 12:00 PM Local Time, 29 December 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: thomas.l.hood26.civ@mail.mil.