A--Operation of a Facility for the Testing of Malaria Vaccines in Adult Human Subjects

The Malaria Vaccine Development Unit (MVDU), NIAID, has a mandate to develop the process for manufacture of pilot lots of clinical grade material of promising malaria vaccine candidate antigens; to produce clinical grade prototype malaria vaccines through collaborations or contract manufacture; to undertake Phase 1 safety and immunogenicity trials in the USA and undertake Phase 1 and Phase 2 studies in populations endemic for malaria. The MVDU program has resulted in eight antigens that either have or are likely in the near future to be prepared as clinical grade antigens suitable for Phase 1 trials. Several other antigens are at an earlier stage of development and some of these are likely to become available during the contract period. Depending on the results on Phase 1 trials of individual antigen and adjuvant combinations, it is expected that these antigens will progress to field testing as three combination vaccines, a mixture of four Plasmodium falciparum blood stage antigens, a mixture of two P. falciparum sexual stage antigens and a mixture of the same two P. falciparum sexual stage antigens with two P. vivax sexual stage antigens. These combinations must be tested in Phase I studies in the USA before they can be taken to an endemic area. The following mandatory qualification criteria establishes a condition that MUST be met at the time of receipt of initial proposals by the Contracting Officer in order for the proposal to be considered any further for award: The Offeror shall demonstrate that their facility where vaccines will be formulated and volunteers vaccinated is approximately one hour travel, and no more than 2 hours under heavy traffic conditions from the MVDU unit at Rockville MD. This requirement is to allow, if necessary, vaccines prepared as - point of injection formulations either at the MVDU facility or at the contractor's facility to undergo QC procedures at MVDU after formulation and prior to injection, while still meeting a 4 hour limit on the time from formulation to injection. This travel limit will also facilitate regular meetings between the Project Officer and other NIAID Investigators and the Offeror. The Government scientists must also have ready access to examine the volunteers and to receive labile clinical specimens (e.g. whole blood samples) obtained from these volunteers. The Government contemplates awarding 1 cost-reimbursement type contract for accomplishing the tasks outlined in the Statement of Work for a period of seven (7) years. RFP NIH-NIAID-DIR-04-01 will be available electronically on or about September 4, 2003, and may be accessed through the NIAID Contract Management Branch (CMB) Home Page by using the following electronic address and instructions: NIAID/CMB Home Page (via the World Wide Web) use http://www.niaid.nih.gov/contract to access the NIAID/CMB Home Page, then click on the Current RFP's link, and select RFP NIH-NIAID-DIR-04-01. Responses to this RFP will be due on December 16, 2003. See Numbered Note 26. Any responsible Offeror may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. Point of Contact: Donald E. Collie, Contract Specialist; Phone: 301-496-0992, E-mail: dc128b@nih.gov; or Thomas P. Hastings, Contracting Officer, Phone: 301-496-0194, E-mail: ph23k@nih.gov; Fax 301-480-5253.