Evaluation of the protective efficacy of a human anti-ETEC antibody product using the Aotus nancymaae model for diarrhea caused by a CFA/I expressing ETEC strain.

The U.S. Naval Medical Research Unit No. 6 (NAMRU-6) in Peru is evaluating the development of an effective prophylactic to control enterotoxigenic E. coli (ETEC) caused diarrhea. Individual vaccine candidates are being evaluated in an established Aotus nancymaae preclinical model of diarrhea. Continued used of the A. nancymaae monkey in these studies is essential for comparative analysis across studies and maintenance of an established model of disease. Background: Non-human primate models of human diarrheal diseases caused by ETEC, Campylobacter and Shigella have been developed at NAMRU6 using A. nancymaae. These models represent a unique asset to test the efficacy of vaccines targeting enteric diseases. To date, candidate vaccines against individual strains of ETEC have been tested in the Aotus non-human primate model. We will now test the protective efficacy of a human anti-ETEC antibody product using the Aotus nancymaae model for diarrhea caused by a CFA/I expressing ETEC strain. For the completion of these studies, we shall require 39 Aotus Nancymaae (Owl Monkeys) non-human primates. All animals shall be of good health. For the scientific consistency and comparative analysis, the delivered Aotus Nancymaae animals must have an equal gender distribution (in so much as possible) and be at 12 months of age and weighing over >700 grams at the time of the initiation of the study. Delivery: December 29 2017 at NAMRU-6 Facilities in Lima Peru. If capable sources are not identified through this notice, then NAMRU 6 intends to award a sole source contract under the authority of FAR 13.106-1(b)(i) to The Instituto Veterinario de Investigaciones Tropicales y de Altura (IVITA), Universidad Nacional Mayor de San Marcos in Lima Peru, for the requirements of the collaborative effort with NAMRU-6. The Instituto Veterinario de Investigaciones Tropicales y de Altura (IVITA), Universidad Nacional Mayor de San Marcos maintains a large, closed colony of Aotus nancymae (owl monkeys) which are made available for research purposes. This species is the principal animal research model for several infectious diseases of interest to our unit's mission. This source is selected for the following reasons: 1. Known health status and genetic composition of the colony. Animals from wild-caught sources in the Amazon basin, because of their unknown health history and parasite burden, are not desirable for biomedical research. Also, the use of the captive-bred population at IVITA negates any impact of acquisition on wild populations of animals and eliminates the possibility of inadvertently supporting the illicit trade of animals. 2. Use of this source eliminates the additional cost and administrative burden required to obtain permits required by the Convention on International Trade in Endangered Species (CITES) as the shipment does not cross an international boundary. 3. Our institution has used this source for its primate purchases over the past 10 years and a considerable body of our research data is based on the use of this animal source. Changing that source will adversely affect the diarrheal model previously established over the past 10 years through potential changes in incidences of disease, and a changing source will make comparisons with historical data impossible. 4. Acquisition within Peru eliminates the transportation stress to the animals associated with extended air travel (relatively short transport by air from Iquitos to Lima). The reduction in transportation associated stress results in decreased requirements for acclimation to the new housing arrangement and greatly reduced rates of stress-induced diarrhea. This pre-solicitation is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice 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 or to proceed with a sole source contract. Capability statements are due by 08:00 AM Local Time, December 10th, 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: Javier.b.gil.fn@mail.mil Please use subject line "N44852_BAC180001_39AO".