B -- Dominican Republic influenza vaccination clinical trial

The Centers for Disease Control and Prevention (CDC) intends to award a contract to Fundaci?n Dominicana de Infectolog?a. This contract will fund recruitment, vaccination, data and specimen collection, and associated administrative and regulatory activities for 402 remaining participants in an ongoing clinical trial of influenza vaccination, formally entitled ?Clinical Trial of Safety (Reactogenicity) and Immunogenicity of Needle free Jet Injection of Reduced-dose, Intradermal Influenza Vaccine (INF) administered to ?d6 -to- <24 Month-old Infants and Toddlers in the Dominican Republic?. Scientific details are online at: http://clinicaltrials.gov/show/NCT00386542. The subjects to be studied under this contract are designated numbers 049 through 450. Subjects 001 through 048 have already been fully studied under previous contract 200-2002-00617 with the Fundaci?n Dominicana de Infectolog?a (FDI), on behalf of its affiliated Department of Infectious Diseases of the Hospital Infantil Dr. Robert Reid Cabral (HIRRC). This institution is the national children?s hospital of the Dominican Republic Secretar?a de Estado de Salud P?blica y Asistencia Social (SESPAS, ministry of health). It is imperative to utilize Fundaci?n Dominicana de Infectolog?a for this contract. FDI?s performance of the preceding phase of this trial was justified under FAR part 6.302.1 on the grounds that it was the only known source with the knowledge, capability, authority, and documented, published experience to conduct clinical vaccine trials among children in the Dominican Republic, according to international standards and within the proposed time frame. This was verified by a Sources Sought notice (solicitation number 2002-N-00357) which was posted online by the U.S. Government on February 01, 2002. There remains no other potential contractor who could perform phase II, given the unique skills required in performing this work, and given the constraints to complete the trial in a timely fashion. Preparation for this trial required several years of preparation, training of staff, and time-consuming permissions solicited from the national regulatory authority for medicines and drugs and hospital and Dominican national and hospital ethical review committees. Trial preparation by another vendor, of which there are none known to be qualified, would be cost prohibitive and would likely require two years of delay in changing approved protocols, obtaining permissions from four ethical review committees (CDC, WHO, and two in the Dominican Republic), and training new physicians, nurses, and laboratory staff. In addition, switching vendors at this time may jeopardize the validity and continuity of this study. The North American Industry Classification Code is 541710. This notice of intent is not a request for competitive proposals, but all replies received within 15 days of publication will be considered. A determination not to compete based on responses received and to proceed with a noncompetitive award is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.