U.S. ARMY MED. RESEARCH ACQUISITION ACT, MCMR-RMA-IC, FORT DETRICK BLDG. 820, FREDERICK MD 21702-5014

B -- SERVICES TO DESIGN & PRODUCE A VACCINE CARRIER TO ELICIT PROTECTION AGAINST MILITARILY RELEVANT VECTOR AND/OR AEROSOL DELIVERED MICROBIAL OR TOXIN CHALLENGE SOL DAMD17-95-#-0005 DUE 050595 POC Rachel Moler, Contract Specialist, (301) 619-2365, or, George Bauman, Jr., Contracting Officer, (301) 619-2369 The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) has the requirement for services of an individual scientist to develop carrier-mediated, controlled, pulsed, and sustained-rate release of vaccine(s) to protect Armed Forces personnel from militarily relevant biological threats. This service is required to comply with objectives of the Medical Biological Defense Research Program (MBDRP) for the development of vaccines as medical countermeasures against toxins and microbial infections. Efficacy of a single dose of vaccine administered on parenteral route should stimulate complete (100%) protection within 2-3 weeks postimmunization, and it should protect at least 80% of the immunized animals after one year. Distinct antibody peaks (booster effect(s)) should be stimulated by a single dose of the vaccine. Furthermore, the vaccines should protect on intranasal and/or oral administration. These requirements can be met with a polymeric vaccine delivery system, a rapidly evolving novel technology, that is uniquely suited for achieving the stated efficacy parameters, and apply this system for protection against BW agents. To exploit the tremendous advantages of vaccine delivery technology and to fulfill MBDRP requirements, all the qualifications and the tasks and qualifications must be effectively accomplished without interruption of the ongoing effort. Tasks include: Characterizing extensively the chemical and physical relationship between each vaccine and the microencapsulation procedure for obtaining at least 50% encapsulation efficiency. Confirm the physical integrity of the microencapsulated vaccine by gel electrophoresis. Apply and explore methods and polymer compositions, which would yield high and low in vitro protein burst for each vaccine. Ensure by proper methods, different distribution pattern for each vaccine in the polymeric matrix, and confirm the pattern with the aid of confocal laser scanning microscopy. Ascertain the surface integrity of the final product with scanning electron microscopy. Synthesize and characterize polymer(s) with the desired copolymer ratios and molecular weights to achieve the optimal differential release kinetics. Produce the suitable microparticle size for the desired route of administration, and confirm the accuracy of the proper distribution by electronic instrumentation. Develop vaccine carriers for stimulation of sustained and pulsed antibody response and resistance to challenge for more than one year. Select for each vaccine the proper conditions for parenteral, oral and intranasal administration, which would stimulate complete protection, with single or minimal number of immunization doses. Develop and produce microspheres, which would be stable in the low pH of the stomach. Develop and produce microparticles with bioadherence properties to facilitate the adherence to the mucosal cells of the upper gastrointestinal tract. Provide suitable amount of microencapsulated vaccine(s) for efficacy testing in animal models. Scale up production to provide large amount of microencapsulated vaccine as needed, and ensure the retention of all desired properties of the small experimental lots. Available to begin productive work within USAMRIID's containment facilities immediately upon award of the contract. The purpose of this synopsis to conduct a market survey to determine the existence of other sources. The proposed contract action will be a continuation of similar work for which the Government intends to solicit and negotiate on a sole source basis for these services with Dr. Changhong Yan, Frederick, MD for award of a contract for a period of one year, with four one-year renewal options. Individuals who believe they can perform this requirement may submit a capability statement addressing the following: Due to high level biocontainment requirements for these agents, the individual must be able to perform the service at USAMRIID's facilities, Ft. Detrick, Frederick, MD. Such individual must have the following qualifications: 1) knowledgeable of all safety guidelines for, and capable of working in a BL-3/BL-4 level containment laboratory with infectious agents and toxins in animal models, including determination of antibody isotypes; 2) be vaccinated for plague, yellow fever, Rift Valley fever, Venezuelan equine encephalitis, botulinum toxin and anthrax, which are required to gain access to certain biological containment suites, with the understanding that most of these vaccine are under Investigational New Drug (IND) development; 3) possess a PhD or Doctor of Engineering in chemistry with demonstrated knowledge and experience in preparing and characterizing a variety of polymers and their use as vaccine carriers; 4) working knowledge in incorporation of hydrophilic and lipophilic vaccines into a variety of carriers, by using relevant bioengineering methods to produce conditions for delayed, sustained and pulsed release kinetics; 5) extensive knowledge and experience in preparation of microparticles and nanoparticles made of poly(lactide-co-glycolide), polymethyl methacrylate, poly(styrene-co-acrolein, poly(styrene-methacrylate, poly(styrene-acrylic acide), poly(styrene-hydroxyethyl methacrylate), heat and pH sensitive graft polymers, gelatin, human and bovine serum albumin, and liposomes; 6) possess theoretical knowledge with a minimum of 10 years experience in the application of polymer chemistry for the treatment of cancer, and for other biomedical purposes; 7) theoretical and working knowledge of protein purification, and immobilization of proteins into microspheric carriers with various methods; 8) possess knowledge to evaluate the properties of immobilized proteins; 9) theoretical and working knowledge to analyze the process of association and dissociation between carrier particles and the ligand; 10) a minimum of 20 publications in medical application of carriers including vaccines of military relevance; 11) demonstrated ability to work safely and effectively with hazardous microbiial agents and plant toxins under high containment conditions; and, 12) sufficient working knowledge to analyze in vitro and in-vivo data with computer software package(s); Capability statements received will be evaluated solely for the purpose of determining whether to conduct a competitive procurement. The above stated information must be submitted in writing (original and one copy) within 15 days after publication of this notice to U.S. Army Medical Research Acquisition Activity, ATTN: SGRD-RMA- IC (Rachel Moler), Ft. Detrick, Frederick, MD 21702-5014. (0108)

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