Added: Jan 09, 2019 4:07 pm
SUMMARY: The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health is announcing an opportunity for a Cooperative Research and Development Agreement (CRADA) for developing protein nanoparticles for the display of viral epitopes for vaccine use. The NIAID seeks to enter into a CRADA with one or more biotechnology or biomedical companies to use protein nanoparticles developed by NIAID for the purpose of vaccine use with one of more of the following capabilities: (i) produce scaled- up purified recombinant protein nanoparticles; (ii) carry out immunogenicity studies in animal models to (a) measure antibody levels/titers elicited by nanoparticles, (b) measure neutralization capacity of antibodies to a panel of influenza viruses, and (c) measure hemagglutination inhibition by antibodies; (iii) produce hydridomas and/or cDNA clones of neutralizing antibody genes elicited by protein nanoparticles; (iv) produce quantities of antibodies sufficient for challenge and protection studies in animal models; (v) carry-out animal challenge and protection studies with influenza viruses and nanoparticles and generate immunological data such as antibody titers, survival curves, and HAI titers; (vi) if the animal data are promising, generate clinical grade materials; and (vii) support clinical studies.
SUPPLEMENTARY INFORMATION: Influenza virus infects millions of people worldwide on an annual basis. Although drugs are available the virus continues to be a major health treat to its ability to produce drug-resistance strains and its antigenic variation resulting in the need for yearly vaccination. Thus, influenza is an important target for the development of more efficacious vaccines.
The current state of the art in influenza vaccines is dominated by the use of live-attenuated viruses and inactivated viruses. Thus, there is the need to grow and produce influenza viruses every influenza vaccine season. The majority of influenza vaccines on the market rely on egg-adapted influenza viruses as sources for vaccine immunogens. However, during the egg- adaption of influenza virus epitopes in immunogens can mutate and may not antigenically match circulating or future influenza strains leading to antigenic mismatch and lowered vaccine efficacy.
NIAID has established expression and purification workflows for several promising nanoparticles. NIAID has characterized the interaction of nanoparticles displayed with influenza epitopes with neutralizing antibodies. NIAID has developed novel protein nanoparticles that display influenza epitopes and in vitro testing indicated that nanoparticles interact with influenza antibodies. Initial immunogenicity and protection studies in a small animal mouse model indicated vaccine proof-of-concept in that antibodies were elicited and animals were protected from lethal challenge with influenza virus.
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.
EVALUATION CRITERIA: CRADA partners will be expected to carry out additional immunogenicity studies in small animal mouse models with NIAID's protein nanoparticles and if the data are promising, clinical studies may be discussed. It is especially desired that a prospective CRADA partner has expertise in performing and analyzing vaccination of animals with influenza immunogens/viruses and has the ability to perform challenge and protection studies in animals with a candidate influenza vaccine to expand on the initial studies performed by NIAID. Regarding clinical studies, if appropriate, CRADA partners should be able to do one or more of the following: 1) have the capacity to recruit volunteers; 2) to provide clinical facilities; and 3) to provide the personnel required to conduct the research, all in coordination with the NIAID principal investigator. Collaborator will be expected to 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, in addition to each of the above listed capabilities: (1) the technical expertise of the partner's principal investigator and laboratory group; (2) the availability and location of manufacturing and testing facilities to carry out the studies; and (3) the ability to provide adequate funding to support performance of the research plan throughout the life of a 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.