SPECIAL NOTICE
A -- Cooperative Research and Development Agreement (CRADA) Opportunity for Evaluating Influenza Vaccines and Therapeutics in an Influenza A Healthy Volunteer Challenge Model
- Notice Date
- 10/17/2013
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-TTIPO-2012-002
- Archive Date
- 11/1/2014
- Point of Contact
- Maryann T. Puglielli, Ph.D., J.D., Phone: 3014516863
- E-Mail Address
-
maryann.puglielli@nih.gov
(maryann.puglielli@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SUMMARY: The National Institutes of Health (NIH) is announcing an opportunity for a Cooperative Research and Development Agreement (CRADA) for evaluating influenza vaccines and therapeutics in an Influenza A Healthy Volunteer Challenge Model developed at the National Institute of Allergy and Infectious Diseases (NIAID). The NIAID seeks to enter into a CRADA with one or more biotechnology or biomedical companies to use the Influenza A Healthy Volunteer Challenge Model developed by NIAID for the purposes of developing new influenza drug treatments or vaccines. SUPPLEMENTARY INFORMATION: The high seasonal morbidity and mortality associated with both pandemic and seasonal influenza, the continued threat of highly pathogenic avian influenza infections, the development and global spread of antiviral resistance, and the need to plan for future influenza pandemics makes influenza a high priority in infectious disease research. Indeed, approximately 30,000 people die each year from complications due to influenza infection in the U.S. alone. Because animal models of influenza are limited in their ability to replicate human disease, new drug development and the search for better vaccines and vaccine strategies will require significant clinical development. Moreover, many important questions about influenza infection can only be approached through human studies of influenza. In an effort to facilitate these clinical studies, NIAID has developed the Influenza A Healthy Volunteer Challenge Model using challenge viruses which are reverse genetics produced and cell cultured wild-type influenza A viruses for use in healthy volunteers under an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). Currently NIAID has an A(H1N1)pdm09 Influenza virus available under an IND and plans to use its method of reverse genetics and cell culture to produce additional influenza strain preparations, including strain A/H3N2, for use in human studies. The Influenza A Healthy Volunteer Challenge Model stands to streamline and reduce the cost of evaluating candidate vaccines and treatments. Specifically, clinical studies of influenza are expensive and inefficient due to the large numbers of subjects needed to determine the efficacy of a new treatment or vaccine, and they are limited in their ability to provide standardized data due to an inability (1) to identify the timing of viral exposure and development of disease and (2) to assess pre-exposure immunity. These factors limit the success of such studies and an investigator's ability to evaluate the efficacy of a vaccine or therapeutic as well as to study the natural history and pathogenesis of this global disease. In a well-characterized challenge model such as this, the number of volunteers needed for subsequent efficacy studies will be smaller and the resulting data more informative. Many important research questions about influenza infection and the resulting immune response can be approached through studies evaluating the impact of influenza vaccines and therapeutics on these aspects of influenza virology. For example, use of an influenza vaccine in NIAID's Influenza A Healthy Volunteer Challenge Model could further the understanding of what components of the anti-influenza immune response are important for protection against influenza infection. Use of a therapeutic in NIAID's Influenza A Healthy Volunteer Challenge Model could provide insights on viral titer and length of shedding and their relation to symptomatic illness, and the emergence of strains resistant to such therapeutics. Depending on the nature of the vaccine or therapeutic being evaluated, broad scientific questions regarding influenza virology and immunology, not limited to the above examples, could be explored. With regard to improving the understanding of influenza infection and the resulting immune response in humans, previous human challenge studies have been used to address some aspects of influenza related illness by evaluating the timing of viral replication, shedding, clinical symptoms, and innate and adaptive immune response. They also proved extraordinarily useful in the development of currently available antivirals. Although the influenza research community clearly identifies a need for these types of studies, in the United States all but one published study were performed prior to 1990, and all had limitations due to the scope of the study or the scientific techniques that were available at the time. Prior to the development of NIAID's model, no virus for the purpose of study in healthy volunteers was available in the U.S. and these studies were not being performed. The first challenge virus, A(H1N1)pdm09, has been evaluated in the NIAID's Influenza A Healthy Volunteer Challenge Model and an optimal dose and well as methods of performing this type of study have been established. This validated model of infection in these volunteers will allow more efficient and cost-effective phase II clinical evaluation of antivirals and vaccines, as noted above, as well as an opportunity to study correlates of protection and the natural history and pathogenesis of influenza in a controlled setting. In NIAID's model, the timing of exposure will be known, a standard dose identified and used, and many other potentially confounding variables controlled for. A CRADA is the anticipated collaborative agreement to be entered into with NIAID pursuant to the Federal Technology Transfer Act of 1986, codified as 15 U.S.C. 3710a, and Executive Order 12591 of April 10, 1987, as amended. A CRADA is an agreement designed to enable certain collaborations between Government laboratories and non-Government entities. A CRADA is not a grant, and it is not a contract for the procurement of goods and services. The NIAID is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, NIAID can contribute facilities, staff, materials, and expertise. The CRADA collaborator can contribute facilities, staff, materials, expertise, and funds. The CRADA collaborator will also have an option to negotiate the terms of an exclusive or non-exclusive commercialization license to subject inventions arising under the CRADA. The goals of the CRADA include the rapid publication of research results and timely commercialization of products, diagnostics, and treatments that result from the research. CRADA partners are currently being sought to evaluate novel therapeutics and vaccines in NIAID's Influenza A Healthy Volunteer Challenge Model in a clinical setting. The clinical facilities and procedures used in the collaborative research should meet criteria set forth by NIAID in the CRADA agreement. The CRADA partner will be expected to work directly with the NIAID principal investigator to assure consistency with NIAID's Influenza A Healthy Volunteer Challenge Model. Studies will be designed (1) to meet the specific efficacy testing needs of each individual product under investigation and (2) to further the investigation of influenza related disease. NIAID's clinical principal investigator has extensive experience with running clinical studies of human influenza, working with animal models of influenza, and both classic and molecular virology studies. This principal investigator also has expertise in the area of antiviral resistance and influenza infections in at-risk individuals and populations. EVALUATION CRITERIA: CRADA partners will be expected to have their own drug or vaccine well characterized, to have Phase I testing complete, and to have their drug or vaccine approved under an FDA IND prior to clinical studies beginning with the NIAID Influenza A Healthy Volunteer Challenge Model. CRADA partners should also have the capacity to recruit volunteers, to provide clinical facilities, and to provide the personnel required to conduct the research, all in coordination with the NIAID principal investigator. In addition, it will be expected that the collaborator would provide funding to supplement the NIAID principal investigator's laboratory budget to support this project. Prospective CRADA partners are expected to provide a written Capability Statement to the contact person indicated in this announcement prior to consideration by NIAID. The Capability Statement must address, with specificity, each of the following selection criteria: (1) a description of the partner's influenza vaccine or therapeutic and its IND status; (2) results of Phase I testing of the vaccine or therapeutic; (3) ability to perform supporting tests (i.e., immunological testing) relevant to the study; (4) the technical expertise of the partner's principal investigator and laboratory group; (5) the availability and location clinical facilities to carry out the study; and (6) the ability to provide adequate funding to support performance of the research plan throughout the life of the CRADA. NIAID will consider executing a Confidentiality Agreement with a prospective CRADA partner to facilitate receipt of the Capability Statement if requested by a prospective CRADA partner.
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