01-5503. Centers for Disease Control and Prevention

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Centers for Disease Control and Prevention (CDC) is seeking a CRADA partner for collaboration to examine the use of CD40L as a molecular adjuvant to enhance the humoral and cellular immune responses to Respiratory Syncytial Virus (RSV) and other viral vaccines. The methods comprise expression of the immune-enhancing CD40L molecule with viral antigens in vaccines or addition of CD40L to viral antigens in vaccines to augment the antibody and cellular immune responses to the vaccine antigens. RSV is one example of a viral agent for which vaccines are sought and for which CD40L might prove to be a safe and effective adjuvant.

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. This opportunity is available until 30 days after publication of this notice. Respondents may be provided a longer period of time to furnish additional information if CDC finds this necessary.

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 for collaboration to examine development of research animal models (particularly for non-human primates) to study both the safety and efficacy of CD40L as a vaccine adjuvant. These animal model systems and vaccines will be used to study the ability of CD40L to enhance the immune response to (RSV) vaccine antigens. These studies will focus on humoral immune responses (eg. viral titers), cellular immune responses (eg. cytotoxicity), cytokines and chemokine expression, quantification of cell subsets at the site of infection (i.e. the pulmonary cell infiltrate) and quantification of viral replication in the lungs. Respondents should provide evidence of expertise in the development and evaluation of anti-viral 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 principal 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 anti-viral (RSV) vaccines;

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

3. Evidence of scientific credibility;

4. Evidence of commitment and ability to anti-viral (RSV) vaccines and;

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

With respect to Government Intellectual Property (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.

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.

Dated: March 1, 2001.

Joseph R. Carter,

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