SOLICITATION NOTICE
A -- Advanced Development of Multivalent Filovirus (Ebola and Marburg) Hemorrhagic Fever Vaccines
- Notice Date
- 9/4/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- BAA-NIH-BARDA-NIAID-DMID-AI2007003
- Response Due
- 12/18/2007
- Archive Date
- 1/2/2008
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. This project will be funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), DHHS, in conjunction with the NIAID, NIH. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for the development of a prophylactic multivalent filovirus vaccine that is capable of protecting against both Ebola and Marburg viruses, utilizing platform technology such that the same basic development and manufacturing process is used to develop each component of the final multivalent vaccine. NOTE 1: This solicitation will NOT support the development of devices for the delivery of vaccines; the development of therapeutic agents and therapeutic vaccines; the development of new animal models or refinement of existing animal models; the design and conduct of Phase 3 clinical trials; nor the development of any adjuvants which are not currently used in FDA-licensed vaccines. NOTE 2: BSL-4 facilities for animal model development, animal model vaccine efficacy testing, and assay development are to be proposed by the offeror(s). However, the Government retains the right to negotiate the most effective and efficient mechanisms for providing such facilities. This solicitation seeks to fund organizations with demonstrated vaccine product development experience to advance development of a prophylactic candidate multivalent filovirus vaccine that protects against both Ebola and Marburg viruses. For the purposes of this solicitation, candidate vaccines need not have been tested in a multivalent manner nor have shown protection against all desired strains of Ebola and Marburg. Candidate vaccines eligible for support must have two characteristics: First, a candidate vaccine must utilize a platform technology such that the same basic development and manufacturing process can be used to develop each component of the final multivalent vaccine; and Second, the proposed platform technology must have been used successfully to demonstrate the efficacy of the vaccine candidate in non-human primate (NHP) Ebola and Marburg challenge models. It is sufficient for the platform technology to have demonstrated protection in a monovalent vaccination/challenge study design, that is, a monovalent Marburg vaccine tested in the Marburg NHP challenge model and a monovalent Ebola vaccine tested in the Ebola NHP challenge model. The target multivalent vaccine must contain/express antigens of SEBOV, ZEBOV, ICEBOV, RAVN, and either Ci67, Musoke, or another closely related strain of Marburg, and must provide for a relatively rapid onset of protection following no more than two doses, post-exposure prophylaxis will also be considered. Protection is defined as proof of concept efficacy (greater than 80% survival) in the NHP challenge model (i.m. route of infection with greater than or equal to 100 pfu of challenge virus). Offerors must propose a well-defined and feasible Product Development Plan for advancing the vaccine candidate by carrying out the following research and development activities as specified in the negotiated Statement of Work: 1) development and update of the Product Development Plan for a multivalent filovirus vaccine candidate, including regulatory, clinical, non-clinical, and manufacturing activities to be undertaken; 2) manufacturing and formulation process development; 3) manufacturing of pilot lot cGMP material; 4) real time and accelerated vaccine stability studies; 5) conduct of non-clinical studies, including all Investigational New Drug (IND)-enabling toxicology studies and multivalent immunogenicity interference studies; 6) development, qualification and, where necessary, validation of all assays and reagents necessary to support product development; 7) development, submission, and sponsorship of an Investigational New Drug (IND) application, including compliance with all regulatory requirements; 8) design, conduct, completion, and analysis of a Phase 1 dose-escalating clinical trial of the multivalent vaccine candidate in healthy subjects ages 18 to 40; 9) the provision of clinical and non-clinical samples from all studies to NIAID and, for clinical trials, obtaining future use consent from volunteers for their samples; and 10) the provision to NIAID of cGMP final container vaccine and all necessary supporting documentation/letters of cross-reference to allow NIAID to perform subsequent clinical trials. OPTIONS: Contracts awarded under this Broad Agency Announcement will include three Options that may be exercised at the discretion of the Government. Options 1 and 2 may be undertaken concurrently. However, Option 3 may not be undertaken until successful completion of the tasks described in Option 1 as determined by the Government. Option 1 provides for performance of all activities associated with the transfer and scale-up from pilot scale to large-scale cGMP manufacturing and release of 200,000 doses minimum target scale of the candidate vaccine for use in further clinical trials. Option 2 provides for the conduct of studies to develop a lyophilized final container formulation to improve vaccine shelf-life and stability. Option 3 provides for the design, conduct, completion, and analysis of a Phase 2 clinical trial to evaluate further the safety and immunogenicity of the candidate multivalent vaccine. It is anticipated that multiple cost-reimbursement, completion type contracts will be awarded. Funding will be consistent with the nature and complexity of the proposed research. It is anticipated that the period of performance for the BASE period will be five years beginning on or about September 20, 2008, with Options to be exercised at the Government?s discretion for a maximum period of performance of 9 years. It is anticipated that each OPTION will cover a period of two years. Options 1 and 2 may be undertaken concurrently. However, Option 3 may not be undertaken until successful completion of Option 1, as determined by the Government. It is estimated that the provision of total FTEs will be as follows: Base Period: 13.85 total FTEs for a 5-year period; Option 1: 3.75 total FTEs for a 2-year period; Option 2: 4.65 total FTEs for a 2-year period; and Option 3: 9.1 total FTEs for a 2-year period. Any responsible offeror may submit a proposal which will be considered by the Agency. This Broad Agency Announcement will be available electronically on/about September 18, 2007, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.
- Record
- SN01393792-W 20070906/070904220253 (fbodaily.com)
- Source
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