SOURCES SOUGHT
R -- Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects
- Notice Date
- 3/20/2014
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, Maryland, 20817
- ZIP Code
- 20817
- Solicitation Number
- NIAID-2014-AMOB-0318-AMS
- Archive Date
- 4/19/2014
- Point of Contact
- Alice M. Sobsey, Phone: 301-402-6545, Dixie Harper, Phone: 301-402-6790
- E-Mail Address
-
alice.sobsey@nih.gov, Dixie.Harper@nih.gov
(alice.sobsey@nih.gov, Dixie.Harper@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. In addition, we are looking for all qualified sources with the capability to perform the required statement of work. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Statement of Work Background and Objectives: The mission of the Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases (LMIV) is to develop malaria vaccines. Clinical trials are needed to investigate initial safety, immunogenicity, and biologic impact of vaccine candidates. Clinical studies may also be conducted as part of pathogenesis research to facilitate vaccine development. The objective of this contract is to assist NIAID investigations and develop of malaria vaccines by examining the safety and immunologic responses to experimental vaccines and to experimental malaria infection in adult human subjects. Project Requirements: The Government requires that can perform malaria vaccine testing, challenge studies and infection research in humans. The contractor will also be involved in clinical protocol development. Potential successful offerors will need to demonstrate understanding of the relevant science/ issues related to vaccine testing and infectivity studies for the particular pathogens, posses appropriately trained and experienced personnel and the necessary facilities. Two species of pathogens are being considered for studies at this time; Plasmodium falciparum and P. vivax. However, the Government may required additional safety and monitoring procedures if the studies include parasites with enhanced virulence. Anticipated period of Performance: One base year starting approximately in September 2014, and including four 12 month option periods. BACKGROUND The mission of the Laboratory of Malaria Immunology and Vaccinology (LMIV) is to develop malaria vaccines. Clinical trials are needed to investigate initial safety, immunogenicity, and biologic impact of promising vaccine candidates. Clinical studies may also be conducted as part of pathogenesis research to facilitate vaccine development. OBJECTIVE The purpose of this requirement is to provide clinical support services, including volunteers, qualified personnel, material, equipment, and facilities to examine safety and immunologic responses to experimental vaccines and to experimental malaria infection as described below. The National Institute of Allergy and Infectious Diseases (NIAID) expects to issue task orders for clinical trials of promising LMIV's vaccine candidates, as required, under Indefinite Delivery Indefinite Quantity Contracts. The contracts' estimated performance period is September 1, 2014 through August 31, 2019. Independently, and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the clinical studies and requirements described below. A. Task Areas: 1.Conduct a minimum of one staggered-start, dose escalating Phase 1a malaria vaccine trial in healthy malaria-naïve adult volunteers. These ‘first in human' vaccine studies will test the safety and immunogenicity of candidate malaria vaccines. Vaccines will be recombinant proteins formulated with one or more adjuvants; viral vectored vaccines and prime-boost regimens may also be tested. Trials will be done in an outpatient setting, except for challenge and experimental infection studies as outlined below. Trials typically will use 40-60 volunteers in escalating dose groups, with 3 vaccinations given over 3-6 months. Safety and immunological assessments (humoral and cellular) will take place after each vaccination and up to one year after completion of vaccinations, as required by study protocols. Samples will be processed as needed and transported to LMIV for immunological assay assessment. LMIV shall provide experimental vaccine products that have been tested for purity and lack of contamination with adventitious agents and that meet safety standards set by the National Institutes of Health (NIH), the Center for Biologics Evaluation & Research, Food and Drug Administration (FDA), and the Clinical Research Review Committees. 2.Conduct a challenge study. Vaccines intended to prevent malaria infection (pre-erythrocytic or liver stage vaccines) may require challenge with malaria parasites to determine protective efficacy (Phase 2a). Such a study will include approximately 20 participants. Participants will be vaccinated and followed up with safety and immunologic assessments as summarized above. After completion of vaccination, consenting participants will be challenged using infected mosquitoes or other proven means of infection, if available. Participants will be intensively followed for the following ~21 days to monitor immune responses and treat malaria infection. Inpatient follow-up will be required, or alternately, volunteers may be housed in a hotel with study staff on site 24 hours/day during the intensive follow up period. The provision of infectious mosquitoes or other infectious materials and the provision of a site suitable for conducting the infectious challenge will be the responsibility of the contractor. Appropriate measures to ensure safety of the study participants and staff conducting the challenges must be taken. Infecting strains homologous to the vaccine are likely to be tested initially, but heterologous challenges may also be conducted. Infected volunteers will be treated orally with drugs (supplied by the contractor) to which the infecting malaria strain is susceptible. Cure will be confirmed by blood smear. Challenges must be done in accordance with safety standards set by the NIH, the Center for Biologics Evaluation & Research, FDA, and the Clinical Research Review Committees. 3.Conduct Experimental Infection Studies. Experimental Human Infection Studies are an invaluable tool to study human malaria pathogenesis and immunity, such as the recent observation that malaria exposure occurring during anti-malarial prophylaxis can induce a sustained high level of protective immunity. In Experimental Infection Studies, 10-15 participants/group would be exposed to infectious or attenuated sporozoites, or infectious or attenuated infected erythrocytes, possibly in conjunction with other measures such as causal or suppressive anti-malarial prophylaxis. Exposure will be through infected mosquitoes or direct injection. Sampling regimens would be tailored to the parasitologic, immunologic, or other scientific objectives of the particular study. Exposure to infectious parasites would take place at set times, as stipulated by the study protocol. The period of follow-up would vary according to the scientific objectives. As an example, participants might receive 3 monthly exposures to infectious sporozoites while receiving anti-malarial prophylaxis, and 2 months later after cessation of anti-malarials would be challenged again with infectious sporozoites; participants would be intensively followed for at least 21 days after challenge to monitor immune responses (both humoral and cellular) and to treat malaria infection, should it occur. An additional group of 5-10 participants would also be infected as controls. Inpatient follow up would be required or, alternatively, volunteers may be housed in a hotel with study staff on site 24 hours/day during the intensive follow up period. Infected volunteers will be treated orally with drugs (supplied by the contractor) to which the infecting malaria strain is susceptible. Cure will be confirmed by blood smear. The provision of infectious mosquitoes or other infectious materials and the provision of a site suitable for conducting the infectious challenge will be the responsibility of the contractor. Appropriate measures to ensure safety of the study participants and staff conducting the challenges must be taken. Experimental infection studies must be done in accordance with safety standards set by the NIH, the Center for Biologics Evaluation & Research, FDA, and the Clinical Research Review Committees. B. Task Order Requirements: 1. Task Orders may be issued during the life of the contract which may require a Phase 1a Malaria Vaccine Study, Challenge Studies, or Experimental Infection Studies. The request for task order proposals (RTOP) for each of these study areas will specify a requirement for delivery of human subject specimens to the Government in the form of either fresh peripheral blood mononuclear cells (PBMCs) and/or cryopreserved PBMCs. 2. The Contractor will be provided draft clinical protocols from LMIV investigators. Protocol objectives and overall design will be developed by LMIV. The Contractor will assist in completing the final draft protocol. Upon LMIV review of the final draft, the Contractor will be responsible for submitting each protocol to the Contractor's Institutional Review Board and obtaining approval. This effort shall be coordinated with LMIV staff for parallel approval by the NIAID Institutional Review Board. The Contractor shall provide all final documents to LMIV. Where investigational applications are required, approved protocols will be filed with the Center for Biologics Evaluation & Research, FDA by NIAID as part of an Investigational New Drug (IND) Application. In addition, the Contractor shall send results of clinical trials and protocol reviews to LMIV to allow fulfillment of regulatory requirements for annual review and adverse event reporting by FDA and the relevant institutional review boards (IRBs). 3. The Contractor shall recruit and select normal adult subjects, i.e., those in good health, meeting the requirements specified by individual protocols. Vaccine trials are expected to enroll 30-60 subjects/protocol; challenge and experimental infection studies are expected to enroll 20-40 subjects/protocol. 4. The Contractor shall provide facilities for documented and secure temperature-controlled storage of investigational vaccines, and provide the staff and facilities (e.g. pharmacy) for point-of-injection formulation where necessary. Typically, this will take place no more than 6 hours prior to injection and follow standard operating procedures developed by LMIV with assistance from the contractor. The contractor will ensure quality control and documentation of procedures in accordance with LMIV Standard Operating Procedures (SOPs). Storage temperatures will be 2-8ºC or -80 ºC, depending on the vaccines being evaluated. 5.The contractor shall be responsible for initial processing, temporary storage, and shipment of samples to the LMIV for evaluation of immunological outcomes (to include at a minimum serum or plasma for assessment of antibody levels, and peripheral blood mononuclear cells [PBMCs] for the assessment of cellular responses). In a typical trial of thirty volunteers, ten samples will be collected over an 18-month period per volunteer. These will be stored in multiple aliquots. The contractor will need to provide secure storage in a monitored -70oC or lower, freezer with a documented inventory control for samples to be assayed by the contractor and will need to provide similar temporary storage and arrange for periodic shipment of samples to the LMIV. The contractor will provide facilities for separation, cryopreservation and storage of lymphocytes from whole blood prior to shipping to the LMIV. Fresh PBMCs may also need to be transported to LMIV, depending on the assays to be conducted in each protocol. Apheresis may be required to obtain large volume serum or plasma, or higher numbers of PBMCs, as per study protocols. The Contractor must deliver specimens as described below and per protocol requirements: a.Fresh peripheral blood mononuclear cells (PBMCs) - delivered within two hours of initial processing and before 2 P.M. Eastern Time (ET) on the day of collection. Initial processing includes a period that is not to exceed a maximum of four (4) hours for sample collection and shipping preparation, and must occur on the same day of the Contracting Officer Representative (COR) requested delivery date. b.Cryopreserved PBMCs - delivered before 4 P.M. ET on the next business day after the COR request date. 6.The Contractor shall develop and maintain a system of records and data management for each study undertaken. This system of records shall be in accordance with the Privacy Act and the Confidentiality of Information clause, which are contained herein. All IND documentation shall be prepared in accordance with FDA and other regulatory requirements. The Contractor shall establish procedures for tracking recruitment, retention and follow-up of study volunteers; this information shall be reported in the progress reports submitted to the COR. All informed consent documents for each protocol shall be co-developed with the COR. The Contractor's files and records are subject to inspection by the Government and all data established and prepared for each protocol are Government property and publications will not be prepared or distributed without Government approval. The Contractor shall maintain up-to-date summaries of all clinical trials including clinical and laboratory data (e.g. on Excel spreadsheets) that can be transmitted electronically to the COR at the COR's request. 7.The Contractor shall provide follow-up of all volunteers enrolled in trials. The Contractor shall continue the clinical evaluation, collection, analysis, storage and shipment of samples, data collection and reporting on all volunteers enrolled during the task period until the completion of the period specified in the protocol or until such tasks can be transferred to a new Offeror approved by the Contracting Officer. 8.As part of each task order completion requirements, the Contractor shall provide for an orderly transition of data and materials to the Government by the task order completion date. The Contractor must transfer to the Government or a Government designated repository, as requested by the Contracting Officer Representative, all remaining Government-supplied reagents, stored volunteer specimens, the original study data and any other information thereto. REPORTING REQUIREMENTS Technical Reports In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERIES of this contract: (1)Semi-Annual Progress Reports (a) This report shall include a description of the activities performed during the reporting period and the activities planned for the ensuing reporting period for each active or completed protocol (task) during the period. The initial report will be submitted for the first full six months of the task order performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months. (2)Annual Progress Report This report includes a summation of the results of the entire contract work for each active or completed protocol (task) during the period. An Annual Progress Report will not be required for the period when the Final Report is due. A Semi-Annual Report shall not be submitted when an Annual Report is due. An original and 2 copies shall be delivered to the COR. An original and 1 copy shall be delivered to the Contracting Officer. (3) Annual Technical Progress Report for Clinical Research Study Populations The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Inclusion Enrollment Report," which is set forth in SECTION J of the contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of the contract. The final report shall be due on. In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. The Guidelines may be found at the following website: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity. (4) Final Task Order Report This report is to include a summation of the work performed and the results obtained for the entire task order period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. An annual report will not be required for the period when the Final Report is due. (6) Summary of Salient Results The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. OTHER DELIVERABLES At the request of the COR, the contractor shall deliver fresh specimens (human PBMCs) to the NIAID-LMIV laboratories in Rockville, MD within two hours of initial processing. Initial processing refers to the proper collection of samples into blood collection tubes and organization of samples for shipping. Initial processing by the trials center shall not exceed a period of four (4) hours for samples initial processing. Samples must then be received at the NIAID-LMIV within 2 hours after initial processing by NLT 2 PM ET. For task orders requiring this specimen type, cryopreserved PBMCs must be delivered to the NIAID-LMIV laboratories by 4 P.M. ET on the next business day after the COR request. Capability statement: Capability statements (limit of 15 numbered pages) must describe the ability to meet the above requirements and provide references for similar work that the offeror has performed, or is currently performing, and the dollar value of that work, and must be submitted to Alice M. Sobsey at alice.sobsey@nih.gov by April 4, 2014. Please CLEARLY INDICATE IN THE FRONT COVER OF THE CAPABILITY STATEMENT, the responding entity's DUNS NUMBER, BUSSINESS SIZE based on the average annual receipts size criteria for NAICS code 541690 (see 13 CFR § 121.104) and the SMALL BUSINESS CLASSIFICATION [i.e. small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses]. 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).
- Web Link
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FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIAID-2014-AMOB-0318-AMS/listing.html)
- Place of Performance
- Address: TBD, United States
- Record
- SN03316478-W 20140322/140320235533-c787ee01b6f4afce1d40b90659367767 (fbodaily.com)
- Source
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