SOURCES SOUGHT
A -- Development of Assays for Characterizing Influenza Viruses - Draft Statement of Work
- Notice Date
- 3/17/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- HHS-CDC-SS-2015-80791
- Archive Date
- 4/16/2015
- Point of Contact
- Thaddeus E Rollins, Phone: 770-488-1971
- E-Mail Address
-
tnr6@cdc.gov
(tnr6@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Development of Assays for Characterizing Influenza Viruses and Detecting Influenza Virus-Specific Antibodies This is a SOURCES SOUGHT notice for market survey to be used for preliminary planning purposes. This request is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS. *See the attachment for DRAFT SOW Background. The Influenza Division at the Centers for Disease Control and Prevention (CDC) is responsible for the detection and characterization of influenza viruses for the purposes of disease surveillance and vaccine strain selection. Tests that measure immunity to influenza and characterize the antigenicity of the virus are critical for detecting influenza infection, understanding the mode of transmission, and selecting viruses to be included in the annual vaccine. New, High throughput and automated assays are necessary to keep up the pace with the testing demands of global influenza surveillance. Development of new assays to support surveillance was initiated several years ago, but updates are required to ensure that the assays can detect newly emerging influenza viruses and to keep up with new technologies. The test most often used to evaluate immunity and antigenicity related to influenza is the hemagglutination inhibition (HI) assay. This assay has been used for over 60 years because it is easy to perform. Data obtained from the assay is essential for World Health Organization (WHO) and Food and Drug Administration (FDA) to make influenza vaccine recommendations. However, this assay is difficult to make mobile, standardize, and automate because it relies on the use of red blood cells, antisera dilutions and humans to read the test results. The purpose of this activity in the contract is to develop new technologies to improve upon the traditional HI assay to make the assay mobile, high-throughput, standardized, and automated. The Influenza Division is also responsible for influenza outbreak investigations, seasonal vaccine strain selections, and vaccine effectiveness studies. There are often situations where the influenza laboratories are not capable of completing research projects due to a significant outbreak or emergence of a new virus subtype thus requiring a shift of testing priorities. In these cases, HI assays, microneutralization (MN) assays, Sanger gene sequencing, Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing for vaccine strain selection and effectiveness studies need to be outsourced to publish study results in a timely manner. Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process. These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands. Influenza pandemics occur when a new strain of influenza virus is easily transmitted to humans. Since 1918 there have been four influenza pandemics, each with different characteristics. The death tolls associated with these pandemics have ranged from ~18,000 to over 50 million. Given the continuous emergence of novel strains, it remains important for pandemic risk assessment purposes to characterize more precisely the frequency of serum cross-reactive antibody to these novel viruses in all age groups in the United States, and to identify past exposure to human influenza viruses that may contribute to differences in the levels of antibodies detected. This information could further be used to assess and better understand the potential for these novel viruses to spread among humans in the United States. It will also serve as a benchmark for incidences of infection in the United States population in the event these novel viruses become more widespread among humans. The purpose of this activity in the contract is to acquire left over sera from various diagnostic laboratories across the United States to establish seroprevalences against emerging novel influenza viruses. Lastly, as part of the USG pandemic preparedness and response, it is important to evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines. The purpose of this activity in this activity is the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy. Purpose and Objectives. The primary purpose of this contract is to study, analyze, advice, research, and develop deliverables to advance CDC's related scientific and technical information (STI) through the application of knowledge and resources in achieving the CDC's mission requirements defined herein. The focus of this contract includes the development of serological and diagnostic assays (for influenza and other infectious disease agents) including a Field Influenza Immunity Test and a High-Throughput Influenza Laboratory Immunity Test. The contract is also focused on the improvement of current serological assays used at CDC (i.e. HI) including the development of a Synthetic HI assay as well as the development of HI automation system. Lastly, this contract will also focus on the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy. To accomplish these tasks, the contractor shall procure left over sera from various diagnostic laboratories across the United States. These sera will also allow for the establishment of seroprevalences against emerging novel pathogens including influenza viruses. As part of the Government pandemic preparedness and response, to the contractor shall test patient specimens via HI, MN, and Sanger sequencing. The contractor will also evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines. Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process. These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands. The contractor shall perform the following tasks: A. Core Requirements 1. Project Management. The contractor will be responsible for planning, organizing, coordinating, and managing all tasks funded during each base or option year. Contractor shall provide routine status reports and deliverables as directed with allowances for special out of cycle reporting as needed to effectively communicate critical issues or special achievements. 2. Field Influenza Immunity Test (FIIT) Development Studies. Serological detection of influenza H2, H5, H7, and H9 infection in the field is important for conducting influenza surveillance for novel or emerging influenza viruses. The current version of the CDC FIIT test was developed under a previous Government contract employing the Dual Path Platform technology from Chembio Diagnostics Systems Incorporated (Medford, NY). The contractor will be responsible for developing a field test/platform that is both sensitive and specific for the serological testing of patient samples. The platform must allow for the testing of multiple antigens including B, H1, H2, H3, H5, H7, H9, H13, or other novel subtype. 3. High-Throughput Influenza Laboratory Immunity Test (HTILIT). The goal of this task is to design, produce, and deliver a High-Throughput Influenza Laboratory Immunity Test (HTILIT) that detects influenza subtype-specific antibody in patient specimens. The current version of the CDC HTILIT was developed under a previous Government contract employing the xMAP technology (Luminex Corporation, Austin, TX). The contractor will be responsible for the development of a High-Throughput assay that is both sensitive and specific and allows for the testing of multiple antigens including B, H1, H2, H3, H5, H7, H9, H13, or other novel subtype. B. Optional Projects 4-7 4. Develop Quantitative ELISAs for Vaccine Potency Testing. As part of the Government pandemic preparedness and response, it is important to evaluate/assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines. The purpose of this task is the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy including those developed with chimeric influenza HAs. The contractor will be responsible for the development of an assay for the testing of various subtypes including but not limited to H1, H3, B, and H7. 5. Synthetic Hemagglutination Inhibition Assay. The goal of this task is to design and deliver a high- throughput influenza binding assay that detects influenza subtype-specific antibody for antigenic characterization. This assay shall also characterize viruses within a subtype as either normal reactors (0 to 4-fold lower than reference virus or vaccine strain) or low-reactors (8-fold or more-lower than reference virus or vaccine strain). Further, the assay or platform should allow for testing of other human and non-human influenza subtypes such as H5, H7, and H9 viruses. 6. Automation of the Hemagglutination Inhibition (HI) Assay. The objective of this task is to implement a more automated HI assay platform in the Influenza Division at the Centers for Disease Control and Prevention in Atlanta. The automated platform shall have the capacity to be integrated with the CDC laboratory information system, and be expandable when technologies and/or increased throughout are available. 7. Biannual Acquisition of Left Over Sera for Seroprevalence Estimations. The objective of this task is to provide a biannual source of left over sera from healthy individuals across the United States to characterize more precisely the frequency of serum cross-reactive antibody to emerging novel viruses including influenza viruses, for pandemic preparedness purposes. The sera acquisition must be representative of both US age population as well as geographic regions. C. Optional Surge Projects 8-15 8. Conduct Sanger Sequencing Testing of Patient Specimens. The Influenza Division at the CDC sequences the HA and NA genes of influenza virus, isolates for vaccine strain selection and research purposes. During periods where test volume is high, the testing of research specimens can be delayed, which interrupts multicenter research projects and negatively affects the performance of associated grants and contracts. Testing of samples must be conducted using a CDC provided protocol or protocols deemed acceptable by the Government. 9. Conduct Serological Testing of Patient Specimens by HI, or MN. One of the Influenza Division's responsibilities is to investigate outbreaks and other emerging infectious diseases and to provide immediate and accurate information for vaccine strain selection and vaccine effectiveness studies. Contractor shall grow the viruses for testing. Further, contractor shall test both human and non-human subtypes including H5, H7, and H9 viruses. Contractor shall have the capacity of testing pathogens in BSL2, BSL2-enhanced and BSL3-enhanced facilities. Training on protocol will be provided at CDC. 10. Conduct Diagnostic and Serological Testing of Patient Specimens by Assay as Defined by Infectious Pathogen. The contractor shall conduct research and public health evaluation activities to develop and assess new diagnostic methods and improve existing diagnostic assays to allow for rapid response to influenza outbreaks or other emerging infectious diseases. Contractor shall have the capacity of testing pathogens in BSL2, BSL2-enhanced, BSL3-enhanced, and BSL4 facilities. Training on protocol will be provided at CDC. 11.Conduct RT-PCR Testing of Patient Specimens. The Influenza Division at the CDC tests patient respiratory specimens by RT-PCT to detect the presence of the influenza virus and to determine the subtype and lineage of influenza viruses in positive specimens. Testing of samples must be conducted using a CDC provided protocol or protocols deemed acceptable by the Government. 12. Conduct Sequencing of Ig heavy and light V(D)J Regions in mouse B cells by Sanger Sequencing or Next-generation Sequencing. One of the Influenza Division's responsibilities is to analyze the immunological response to influenza vaccination and infection, both to determine the protective response induced by seasonal vaccines and to assess the potential efficacy of novel vaccines. Sanger Sequencing: The contractor shall perform Sanger sequencing on RNA, cDNA, or amplicons prepared at CDC from B cells, and document the sequence of both heavy and light chain variable genes and the constant region to the CDC. Sequencing shall be performed with both forward and reverse reactions, as needed to achieve at least 99% unambiguous results. Training on protocol will be provided at CDC. Next-generation Sequencing: The contractor shall perform high-throughput sequencing on RNA, cDNA, or amplicons prepared at CDC from B cells, using a "next-generation sequencing" (NGS) platform such as (but not limited to) PacBio RS II systems, and document the sequence of both heavy and light chain variable regions to the CDC. Training on protocol will be provided at CDC. 13. Cell-mediated immune assessment. The determination of Vaccine Effectiveness (VE) is critical during the influenza season. A suboptimal response to the vaccine may negatively affect the health care systems during the cold and flu season. The contractor shall assess cell-mediated immune responses consisting of T and B cell responses in a subset of participants that received influenza vaccination. 14. Antibody binding avidity studies. Determination of the antibody avidity post influenza vaccination can help assess the vaccines efficacy to drifted seasonal or pandemic viruses. The contractor shall assess antibody binding to recombinant hemagglutinin HA by bio-layer interferometry on an Octet Red Instrument (ForteBIO) or a similar technology using the recombinant HA from vaccine strains and additional strains from circulating strains. Training on protocol will be provided at CDC. 15. Studies to characterize neuraminidase antibody response and Antibody Dependent Cellular Cytotoxicity (ADCC) response post influenza: vaccination. Antibodies to the Neuraminidase can prevent the release and spread of the influenza viruses. Influenza vaccines can generate varying amounts of antibodies to the neuraminidase depending on the host and the vaccine. To assess cell-mediated mechanisms and help determine the effectiveness of influenza vaccines, the contractor shall assess Antibody Dependent Cellular Cytotoxicity, Complement-mediated cytotoxicity, and Neuraminidase antibody level on sera provided by the Government. Training on protocol will be provided at CDC. Anticipated period of performance. The period of performance shall be twelve (12) months base year with four (4) option years, twelve (12) months each. Capability statement /information sought. In order for us to know if the capacity at your company or organization may be suitable for administering one or more aspects of this large scale project, please provide answers to the following Please explain, in detail, your experience, knowledge and ability to provide the following: 1. Your opinion about the difficulty and or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. 2. Information regarding the specific tasks that may be performed by the contractor and tasks that may require subcontracting. If subcontracting is needed, please describe the labor categories may be covered via subcontracting. 3. Your staff expertise, including your availability, experience, and training. 4. Your current in house capability and capacity (including BSL3-enhanced and BSL4 facilities) to perform the work (describe facilities and number of trained staff). 5. Brief summary of your completed projects of similar scope and nature, including tasks performed through formal subcontracts, formal/informal collaborations, and grants (please reference the appropriate task in the solicitation). 6. Your corporate experience and management capability. Provide any examples of prior completed Government contracts, reference, and other related information. 7. Provide a rough order of magnitude (estimated cost) of the effort or time that may be required for completion of the work. Information Submission Instructions: Please include a cover page with the following business information: a) DUNS; b) Organization name and address; c) Do you have a Government approved accounting system? If so, please identify the agency that approved the system. d) Business size and type of business, (e. g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code 541712, size standards in number of employees which is 500. e) Point of Contact, phone, fax and email address of individuals who can verify the demonstrated capabilities identified in the response. Page Limitation: Capability Statements shall be limited to 10 single-spaced pages including cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date : Submit capability statements and questions via email to Thaddeus Rollins, Contracting Officer at tnr6@cdc.gov. Questions are due no later than March 25, 2015 and responses must be submitted not later than 12:00 pm, Eastern Standard Time (EST) by April 01, 2015. Capability statements will NOT be accepted after the due date. The Government will not return capability statements received. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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(https://www.fbo.gov/spg/HHS/CDCP/PGOA/HHS-CDC-SS-2015-80791/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03670661-W 20150319/150317235725-a8f3cb5cf9d1ec3724cf6e56f229e17e (fbodaily.com)
- Source
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