A--Sole Source for non-personal services to assess the safety and immunogenicity of US licensed rabies vaccine using various schedule and delivery methods and execute basic research activities.

The United States Army Medical Research Acquistion Activity (USAMRAA), Fort Detrick, MD intends to issue a sole source award to the Research Foundation of the State University of New York (SUNY), on behalf of Upstate Medical Center, Syracuse, NY for non-personal services to assess the safety and immunogenicity of US licensed rabies vaccine using various schedule and delivery methods and execute basic research activities to include: a. Developing a clinical protocol and supporting documents (i.e. consent form and source documents) designed to assess the safety and immunogenicity of administering licensed rabies vaccine using various schedules and administration techniques in a select population of healthy volunteers; b. Acquiring local regulatory approvals; c. Establishing local clinical lab services to support safety assessments; d. Establishing local blood specimen collection and processing services according to government standard operating procedures(whole blood, sera, PBMCs); e. Establishing local vaccine and blood specimen cold storage facilities meeting government standards; f. Developing volunteer recruitment tools and implementation of said tools to recruit volunteers; g. Completing the informed consent process with potential volunteers; h. Enrolling and vaccinating study volunteers as outlined in the protocol; i. Collecting and processing volunteer blood specimens as outlined in the protocol; j. Collecting clinical safety and laboratory data as outlined in the protocol; k. Developing an electronic study database; l. Completing data entry; m. Completing clinical monitoring services; n. Completing data analysis; o. Completing proteomic immunogenicity analyses of vaccine volunteer blood samples; and p. Leading the development of a final clinical study report. This notice of intent is for information purposes only. All sources eligible to provide this service must respond in writing. Responses must be supported with clear and convincing evidence to clearly articulate the ability to provide services outlined above. A request for documentation will not be considered as an affirmative response. If no responses are received, within 15 days after publication of this notice, to the effect that comparable services are available, and that it is more advantageous to the Government than obtaining these services through a sole-source contract, then a sole source acquisition award will be made. Response to this notice is to be sent to contact@example.gov. .