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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." 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 require additional safety and monitoring procedures if the studies include parasites with enhanced virulence. Anticipated period of Performance: One base year starting approximately in June/July of 2012, and including four 12 month option periods. STATEMENT OF WORK 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 Statement of Work using their best effort to perform clinical studies as follows: 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 NIH, the Center for Biologics Evaluation & Research, 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 and will be intensively followed for the following 21 days to monitor immune responses and treat malaria infection. Inpatient follow-up with 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. Proposals including collaborators or subcontractors (for example, for the challenge or infection portion of a Phase 2a vaccine study or experimental infection study) must address the team management plan under sub-factor C of the Technical Approach. 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. 4. Additional trials (including challenge and experimental infection studies) during the first contract year and in up to six subsequent years will be available to LMIV on an optional basis. 5. Collaborate with LMIV investigators to draft clinical protocols as required by the Project Officer (PO). Protocol objectives and overall design will be drafted by LMIV. Both parties will subsequently participate in drafting the final protocol, and with compiling data necessary for presentation and publication of results. The Contractor will be responsible for obtaining approval for each study/protocol from the Contractor's Institutional Review Board and will coordinate with NIAID staff for approval by the NIAID Institutional Review Board. Where investigational applications are required, the Contractor shall provide approved protocols to the Project Officer to 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 the NIAID Investigational New Drug Coordinator to allow fulfillment of regulatory requirements for annual review and adverse event reporting by FDA and the relevant IRBs. 6. 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. 7. The Contractor shall provide facilities for documented and secure 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 in consultation with the contractor. The contractor will ensure quality control and documentation of procedures in accordance with LMIV SOPs. Storage temperatures will be 2-8ºC or -80 ºC, depending on the vaccines being evaluated. 8. The contractor will 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 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 at 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. Apheresis may also be required to obtain large volume serum or plasma, or higher numbers of PBMCs, as per study protocols. 9. 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 Project Officer. All informed consent documents for each protocol shall be co-developed with the Project Officer. 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 Project Officer at the Project Officer's request. 10. The Contractor shall provide follow-up of all volunteers enrolled in trials prior to the end of the seven-year contract. The Contractor shall, at the approval of the Contracting Officer, continue the clinical evaluation, collection, analysis, storage and shipment of samples, data collection and reporting on all volunteers enrolled during the seven - year contract period from the end of the contract 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. 11. Three months prior to the end of the seventh year of this contract, the Contractor shall provide for an orderly transition of data and materials, including stored volunteer specimens and government-supplied reagents, to a successor Contractor or to the government, subject to the Contracting Officer's approval, and shall deliver, if requested by the Government, by the completion date of the contract, the following items; original data, remaining Government-supplied reagents, volunteer specimens and any necessary information related thereto, and Government-owned equipment and property. 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 Ivan Hernandez at
[email protected] by October 21, 2011. 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 541711 (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)."