Immunogenicity and Protective Efficacy of Multi-clade Consensus ENV SHIV Virus-live Particle Vaccine Study

NOTICE OF INTENT TO SOLE SOURCE: The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Diseases (CCID), National Center for HIV/AIDS, Viral Hepatitis, STD and TB (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) announces its intention to negotiate a sole source award for the purchase of 24 male rhesus macaques with the University of Puerto Rico, Medical Sciences Campus, Caribbean Primate Research Center. The purpose of the longitudinal study is to 1) evaluate the immunogenicity in animals of non-replicating multi-clade and single clade consensus HIV-1 envelope virus-like particle vaccines, 2) determine whether transmission of repetitive intra-rectal challenges of pathogenic SHIV-C can be prevented in immunized macaques, and 3) evaluate immunized animals before, during and after repeated mucosally administered virus challenges. Specifically, the Contractor shall perform the following tasks in this project: Task 1: Identify 24 male rhesus macaques for the project longitudinal study. Task 2: Administer vaccine formulations at four time points according to the schedule. Task 3: Administer weekly intra-rectal virus challenges to the rhesus macaques. Task 4: Collect and monitor blood samples from male rhesus macaques, following the appropriate bleeding schedule, for a total of 12 months per phase. Blood samples shall be monitored for the following: Frequency and absolute numbers of CD4+ and CD8+ T cells Hematologic chemistry and CBC, at described frequencies Task 5: Isolate and Freeze PBMC from blood samples. Task 6: Collect rectal and broncho-alveolar washes following the appropriate schedule. Task 7: Monitor animal health for symptoms of adverse reactions, as characterized by hemogram abnormalities, cachexia, loss of CD4+ T cells, etc. These animals shall be monitored for 12 months unless they develop severe adverse reactions as described resulting in loss of body weight of 25 percent for two consecutive months. If that occurs, the macaques shall be euthanized. Task 8: At the bleeding schedule provided, collect, process, package and ship requested blood specimens for overnight delivery to CDC, for in vitro virologic & immunologic evaluations. Specimens are to be shipped in accordance with IATA regulations at website: (http://www.iata.org/index.htm). The anticipated period of performance will be 24 months from the award date. The University of Puerto Rico is the only source to provide the specific quantity, type, weight, gender, and critical timeframe deemed necessary by CDC. Hence, a contract with the University of Puerto Rico, Medical Sciences Campus, Caribbean Primate Research Center would be the most efficient and cost effective way to deliver services that are critical and essential to meet CDC's requirement. CDC intends to negotiate this requirement with the University of Puerto Rico, Medical Sciences Campus, Caribbean Primate Research Center under the authority of FAR 6.302-1, HHSAR 306.302-1, and 10 U.S.C. 2304(c) (1). Any other responsible sources may submit a statement of qualifications and experience which, if timely received, will be evaluated by CDC to determine if a competitive solicitation should be issued. Inquiries must be received on February 23, 2009, at 10 AM, Eastern Standard Time (EST). Collect calls will not be accepted. Responses may be E-mailed to Betty Vannoy at bbv9@cdc.gov. Questions concerning this proposed acquisition may be directed to Betty Vannoy, Contract Specialist.