SOLICITATION NOTICE
R -- Operation of a Facility Testing Malaria Vaccines in Adult Human Subjects - SOW
- Notice Date
- 7/16/2014
- Notice Type
- Presolicitation
- 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
- NIHAO2014015PS
- Archive Date
- 8/15/2014
- Point of Contact
- A.M. Sobsey, Phone: 3014026545, 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
- Statement of Work Background and Objectives: 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. The objective of this contract to provide clinical support services under the guidance of LMIV, including volunteers, qualified personnel, material, equipment, and facilities to examine safety and immunologic responses to experimental vaccines. Project Requirements: The Government requires an offeror that can perform malaria vaccine testing. 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. Plasmodium falciparum is the pathogen being considered for study at this time. Anticipated period of Performance: November 1, 2014 through June 1, 2016. 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 under the guidance of LMIV, including volunteers, qualified personnel, material, equipment, and facilities to examine safety and immunologic responses to experimental vaccines as described below. The National Institute of Allergy and Infectious Diseases (NIAID) expects to issue a contract for one clinical trial task order. The contract's estimated performance period is November 1, 2014 through June 1, 2016. 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 Area: Phase 1 Malaria Vaccine Trial. 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 following an LMIV provided protocol. The trial will use 35 volunteers in escalating dose groups, with 2 vaccinations given over 3-6 months. Safety and immunological assessments (humoral and cellular) will take place after each vaccination and up to six months after completion of vaccinations, as required by study protocols. Samples will be processed as needed and transported to LMIV for immunological assay assessment per LMIV directions. 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. B.Task Order Requirements: 1.The Contractor will be provided a draft clinical protocol 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 the 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 IRB documents to LMIV. Where an investigational application is required, the approved protocol 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 the clinical trial 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). 2.The Contractor shall recruit and select normal adult subjects, i.e., those in good health, meeting the requirements specified by the protocol. The vaccine trial is expected to enroll 35 subjects. 3.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. Vaccine storage and administration will 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. 4.The contractor shall be responsible for initial processing, temporary storage, and shipment of samples to the LMIV per protocol 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. Apheresis may be required to obtain large volume serum or plasma, or higher numbers of PBMCs, as per study protocol. The Contractor must deliver specimens as described below to LMIV at 5640 Fishers Lane, Rockville, MD 20852: Cryopreserved PBMCs - delivered between 8 A.M and 4 P.M. ET on the next business day after the COR request date. 5.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. 6.The Contractor shall provide follow-up of all volunteers enrolled in the trial. 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. 7.As part of the 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 the 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 the 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. 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 Cryopreserved PBMCs must be delivered to the NIAID-LMIV laboratories at 5640 Fishers Lane, Rockville, MD 20852 between 8 A.M and 4 P.M. ET on the next business day after the COR request.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIHAO2014015PS/listing.html)
- Place of Performance
- Address: NIAID-LMIV Laboratories, 5640 Fishers Lane, Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN03426935-W 20140718/140716234806-9332da8649f0270baf065279b02d0077 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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