SOLICITATION NOTICE
A -- Extension of services for the NOR211 Clinical Trial
- Notice Date
- 3/23/2018
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- ExtendNOR211Trial
- Archive Date
- 4/23/2018
- Point of Contact
- Cheryl Vendemia, Phone: 3016196004, Thomas L. Hood, Phone: 3016199236
- E-Mail Address
-
cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil
(cheryl.r.vendemia.civ@mail.mil, thomas.l.hood26.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent The Naval Medical Logistics Command (NMLC) intends to award a sole source award (via modification) for continued research and development efforts for Naval Health Research Center's (NHRC's) NOR-211 clinical trial, in support of NHRC, 140 Sylvester Road, San Diego, CA 92152. These services are currently being provided under a non-severable contract/task order W911QY-11-D-0053/0015, awarded to the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). Due to unforeseen delays in the project, primarily due to delays in the Government IRB approvals and the recent absence of Norovirus outbreaks in the Great Lakes area, in order to complete the clinical trial and for the Government to obtain a benefit from the services provided, additional time and effort is required to complete the project. It is estimated that an additional six-months of services provided by HJF will result in completion of the clinical trial. The IRB-reviewed and approved clinical vaccine trail protocol designated NOR-211 is a Phase IIb, Randomized, Placebo Controlled, Double-blind, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in Healthy Adults. The modification to the existing non-severable services contract/task order will extend the period of performance by six months, from 30 April 2018 to 30 October 2018, with an estimated increase of $1.3M, in order to gain and compile research data to successfully complete the clinical trial. The purpose of the NOR-211 study is to demonstrate the efficacy and expand data on the safety and immunogenicity profile of this new, investigational Norovirus (NoV) vaccine, evaluate the immune response to the NoV vaccine when given with other vaccines, as well as the potential effects the NoV vaccine has on the immune response to the other vaccines received at the same time and vice/versa. The NOR-211 study will help prepare for a future Phase III study where the vaccine will be used to assess whether it can prevent NoV illness in U.S. Navy Recruit Training settings. Study subjects include consenting voluntary Navy recruits entering basic training at Naval Station Great Lakes, IL. Based on the progression of the research thus far, the proposed modification to increase performance for six months will allow for research efforts to include additional study participants in order to carry out the study protocols to successfully evaluate the immune response to the NoV vaccine when given with other vaccines, the potential effects the NoV vaccine on the immune response, and to the other vaccines received at the same time. Without the additional work and extended period of performance, an adequate study sample cannot be achieved. In addition, as a result of the lack of norovirus cases, an increased number of research subjects were enrolled in the study later than anticipated, requiring additional time to complete patient safety follow-ups, in compliance with FDA study regulations. Without the additional time and effort, patient safety follow-ups would not be completed. In addition, without the additional time and effort, it would not be possible to provide patient safety follow-ups for the most recent/to be enrolled subjects, gather the data, and prepare it for evaluation. The contractor will continue to provide research support for the NOR-211 clinical trial. In coordination with the NHRC Principal Investigator, the contractor will continue to carry out the NOR-211 clinical study in accordance with the IRB-approved protocol. The contractor will provide personnel with the research expertise and familiarity with this ongoing clinical trial. The personnel will provide the overall day-to-day management and conduct of the NOR-211 protocol elements to ensure successful completion of the objectives and outcomes set forth in the protocol, ensuring adherence to quality standards and good clinical practices. Aspects of service consist of, but are not limited to, the following: • assist with coordinating assigned research studies in accordance with approved protocol and applicable local and state and federal regulations while promoting the safety and confidentiality of research subjects and their data at all times, • meet with potential research subjects; explain the research project in detail and determine if subject meets study eligibility based on the protocol's delineated inclusion and exclusion criteria, • enroll eligible subjects into the study by obtaining a fully completed signed/written informed consent document, • perform blood draw processing and blood and serum processing according to federal and state regulations, • administer all study-related vaccinations using good clinical practices, • complete all appropriate study-related document(s) to ensure correct vaccines (investigational vaccine or placebo) were administered to each study subject, • conduct and document investigational vaccine and placebo inventories, • ensure study materials and equipment are available to perform daily study functions, • maintain complete and accurate drug and equipment accountability, • ensure analysis and recorded test data reports form a consistent narrative, • provide administrative support for the management of generated research data as necessary, • ensure proper closure of each research subject, • coordinate shipping of specimens from study sites, and • ensure all regulatory and protocol requirements are met, including patient-safety follow-ups. The period of performance for the entire task order, inclusive of performance during this six month extension, is expected to be 2 Dec 2015 to 30 October 2018. If capable sources are not identified through this notice, NMLC intends to award a sole source modification under the authority of FAR 6.302-1 Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), 6720-A Rockledge Drive, Suite 100, Bethesda, MD 20817. 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 1 (8.5 x 11 inch) page 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 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 9:00AM Local Time, 9 April 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: cheryl.r.vendemia.civ@mail.mil AND thomas.l.hood26.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/ExtendNOR211Trial/listing.html)
- Place of Performance
- Address: NHRC, 140 Sylvester Road, San Diego, CA 92152 and Naval Station Great Lakes, MI, Great Lakes, Michigan, 60088, United States
- Zip Code: 60088
- Zip Code: 60088
- Record
- SN04864911-W 20180325/180323231107-d10723ec581743f073e8d510c1a1b35a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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