SPECIAL NOTICE
A -- Request for Information: In-Patient Clinical Service Support to Phase I Dengue Challenge Trial
- Notice Date
- 1/27/2017
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- RFI-DM-DCT-FY17
- Archive Date
- 2/28/2017
- Point of Contact
- Douglas A. Medcalf, Phone: 3016192394
- E-Mail Address
-
douglas.a.medcalf.civ@mail.mil
(douglas.a.medcalf.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI) 1.0 RFI TITLE: In-patient Clinical Service Support to Phase I Dengue Challenge Trial 2.0 AGENCY: United States Army Medical Research and Materiel Command 3.0 OFFICE: United States Army Medical Materiel Development Activity 4.0 LOCATION: Fort Detrick, Maryland 5.0 SUBJECT: The U.S. Army Medical Research and Materiel Command (USAMRMC) requests information regarding availability of clinical sites with in-patient clinical care services capabilities to support the execution of the challenge phase of a Phase 1, Randomized, Open-label, Single-center, Study of Tetravalent Dengue Purified Inactivated Vaccine (TDENV-PIV) and Live Attenuated Vaccine (LAV) Dengue Vaccine Platforms as part of a Heterologous Prime-boost Strategy in Healthy Adults in a Nonendemic Region. 6.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained. 7.0 DESCRIPTION: U.S. Army Medical Research and Materiel Command (USAMRMC) seeks information from available clinical site services for clinical in-patient (hospitalization) support for the execution of an Office of the Surgeon General (OTSG), Army-sponsored Phase I Dengue Vaccine Challenge trial (Study). During the Study, subjects who have been previously vaccinated with the TDENV-PIV and LAV Dengue Vaccine will be screened, enrolled and challenged using near wild-type dengue viruses developed for the Dengue Human Infection Model (DHIM) by USAMRMC. In general, the Study will consist of the following phases: 1. Screening and enrollment 2. Challenge 3. Hospitalization 4. Follow-up 5. Close-out The Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) will conduct phases 1-2 and 4-5 exclusively. The information requested will address all support activities associated with the Hospitalization phase (3) of the Study. These activities must be conducted in compliance with (but not limited to) the following regulatory requirements: 21 CFR parts 11, 50, 5, 56 and ICH guidance documents E6, E2A, and E8, as required, in order for the Study to remain in compliance and acceptable for FDA submission. Information requests should also include activities related to preparatory activities, coordinate local IRB approvals, and conduct necessary study close-out activities; specifically in reference to Hospitalization phase. As this support is needed primarily for the Hospitalization phase, potential contract awardee will need to work in close coordination with the WRAIR CTC and the study Principal Investigator (PI). It is expected that up to 20 Study volunteers in all groups will be inoculated with the DHIM dengue virus challenge strain at WRAIR CTC during the challenge phase (2). The Hospitalization phase will initiate (for each subject) pending the development of signs or symptoms of dengue fever (DF) as identified by WRAIR CTC Study personnel. Upon the detection of DF, the Study PI (or designee) will contact the Hospitalization phase PI (or designee). The Hospitalization phase PI (or designee) will then coordinate and provide transportation of the volunteer to the contractor's clinical care facility; such that adequate (infectious diseases with experience in the treatment of dengue fever) clinical care can be provided to the subject in a way that ensures subject safety while maintaining compliance with the aforementioned regulations. This would include the availability Intensive Care to include continuous cardiac monitoring, 1:1 nursing, IV fluids, IV vasopressors and mechanical ventilation if needed. In doing so, the contractor will utilize an MRMC-provided clinical data management system (system training will be provided by USAMRMC) and conduct any safety reporting as per protocol. 8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper addressing the above capability (maximum of five pages, not including cover page, index or list of references). The subject header of the email for submission of questions and/or the RFI response shall be: USAMRMC/ USAMMDA In-patient Clinical Service Support to Phase I Dengue Challenge Trial. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately. Submission should include the following information: 8.1 A description of similar work conducted, if any, including vaccine clinical trials, or clinical trials requiring hospitalization; 8.2 A description of capacity to provide clinical care in the specialty of infectious diseases and critical care, in particular dengue virus infections; 8.3 A description of the clinical facility, its infectous disease ward(s) and its capacity to provide biospecimens collection and biospecimen monitored cold-chain storage for up to 20 subjects requiring hospitalization simultaneously; 8.4 A statement regarding properly accredited Independent Review Board (IRB) at clinical facility; 8.5 A statement regarding ground distance between clinical facility and WRAIR CTC and a summary of ground transportation capabilities for subjects requiring hospitalization; 8.6 An estimate of required lead time to obtain IRB approval and complete required preparation ahead to start of the hospitalization phase; 8.7 An estimate of the projected cost; 8.8 Responder's complete contact information (telephone, physical address, and email address). 9.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Doug Medcalf at douglas.a.medcalf.civ@mail.mil no later than the close of business 27 February 2017 (4PM). Telephonic communication will not be considered as submission nor receive response.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/RFI-DM-DCT-FY17/listing.html)
- Record
- SN04384114-W 20170129/170127234734-ed1e84a25804280967f06497e57b7d23 (fbodaily.com)
- Source
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