01-28147. Cooperative Research and Development Agreement (CRADA)

AGENCY:

Centers for Disease Control and Prevention (CDC), Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) is seeking a CRADA partner(s) for collaboration to utilize the newly acquired knowledge that the CX3C chemokine region in the respiratory syncytial virus (RSV) G glycoprotein binds to the chemokine receptor CX3CR1 and this binding facilitates RSV infection of cells and induces chemokine-like responses to develop ways to treat or prevent RSV disease. The CRADA partner could be involved in all or part of studies examining (1) alteration of the CX3C region in the G glycoprotein of live viruses in such a way as prevent CX3C interaction with the CX3C receptor (CX3CR1) on cells and improve the safety and/or efficacy of a live virus vaccine; (2) alteration of the G glycoprotein to enhance induction of antibodies that block G glycoprotein binding to the CX3C chemokine receptor, CX3CR1, and treat or prevent RSV disease; (3) development of reagents (drugs, antibodies, peptides, polypeptides, etc.) that block interaction of the CX3C region in G glycoprotein with CX3CR1 on cells to treat or prevent RSV disease; (4) development of assays to detect blocking of G glycoprotein binding to the CX3C receptor, CX3CR1, or detect blocking of the biological activity initiated by G glycoprotein binding to CX3CR1 to identify reagents (drugs, antibodies, peptides, polypeptides, etc.) or evaluate candidate vaccines that might be used as prophylactic or therapeutic treatments for preventing RSV disease.

Because CRADAs are designed to facilitate the development of scientific and technological knowledge into useful, marketable products, a great deal of freedom is given to Federal agencies in implementing collaborative research. The CDC may accept staff, facilities, equipment, supplies, and money from the other participants in a CRADA; CDC may provide staff, facilities, equipment, and supplies to the project. There is a single restriction in this exchange: CDC MAY NOT PROVIDE FUNDS to the other participants in a CRADA.

DATES:

This opportunity is available until December 10, 2001. Respondents may be provided a longer period of time to furnish additional information if CDC finds this necessary.

ADDRESSES:

The responses must be made to: Lisa Blake-DiSpigna, Technology Development Coordinator, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical: Ralph A. Tripp, Ph.D., Respiratory and Enteric Viruses, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE., Mailstop G-09, Atlanta, GA 30333, telephone [phone].

Business: Lisa Blake-DiSpigna, Technology Development Coordinator, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd. NE., Mailstop C-19, Atlanta, GA 30333, telephone [phone] or by E-Mail at [e-mail].

SUPPLEMENTARY INFORMATION:

The goal of this CRADA is to seek a partner(s) for collaboration to develop studies examining (1) live RSV vaccines produced by modifying the RSV G glycoprotein CX3C region to render it nonfunctional for viral attachment to host cells, (2) producing live or non-live RSV vaccines, or improving existing live or non-live RSV vaccines by modifying the CX3C region or proximal regions thereof so that when administered, higher titers of antibodies are produced that block the biological activity of the CX3C region on the G glycoprotein of subsequently infecting RSV viruses, (3) treatment provided by administration to an RSV infected individual an effective amount of a drug, antibody, peptide, polypeptide, or other molecule that block interaction of the CX3C region in G glycoprotein with CX3CR1 on host cells or the biological activity of the CX3C region in the G glycoprotein, and (4) development of assays to detect blocking of G glycoprotein binding to the CX3C receptor, CX3CR1, or detect blocking of the biological activity initiated by G glycoprotein binding to CX3CR1 to identify reagents (drugs, antibodies, peptides, polypeptides, etc.) that might be used as prophylactic or therapeutic treatments for preventing RSV disease.

Respondents should provide evidence of expertise in all or one of the following areas including the development and evaluation of RSV vaccines and vaccine agents, evidence of experience in animal models systems including non-human primate models, commercialization of vaccines and vaccine agents, and supporting data (e.g., publications, proficiency testing, certifications, resumes, etc.) of qualifications for the principle investigator who would be involved in the CRADA. The respondent will develop the final research plan in collaboration with CDC.

Applicant submissions will be judged according to the following criteria:

(1) Expertise in development and evaluation of RSV vaccines;

(2) Expertise in evaluation of RSV vaccines in animal model systems including non-human primates;

(3) Evidence of scientific credibility;

(4) Evidence of commitment and ability to produce RSV vaccines; and

(5) Evidence of an existing infrastructure to commercialize successful technologies.

With respect to Government IP rights to any invention not made solely by a CRADA partner's employees for which a patent or other IP application is filed, CDC has the authority to grant to the CRADA partner an exclusive option to elect an exclusive or nonexclusive commercialization license. This option does not apply to inventions conceived prior to the effective date of a CRADA that are reduced to practice under the CRADA, if prior to that reduction to practice, CDC has filed a patent application on the invention and has licensed it or offered to license it to a third party. This CRADA is proposed and implemented under the 1986 Federal Technology Transfer Act: Public Law 99-502, as amended.

Dated: November 5, 2001.

Karen Groux,

Deputy Associate Director for Management and Operations, Centers for Disease Control and Prevention.