NOT-AI-02-019: RFP ANNOUNCEMENT: PRODUCTION AND TESTING OF VACCINES AGAINST ANTHRAX � NIH-NIAID-DMID-02-26

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RFP ANNOUNCEMENT: PRODUCTION AND TESTING OF VACCINES AGAINST ANTHRAX NIH-NIAID-DMID-02-26 Release Date: April 18, 2002 NOTICE: NOT-AI-02-019 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Receipt Date: June 6, 2002 DESCRIPTION The main objectives of this RFP are: (a) to develop a rPA vaccine, (b) to assess the safety and immunogenicity of rPA in humans, (c) to assess protection provided by rPA in appropriate animal models of the inhalation disease, when administered in accordance with a pre-exposure and a post- exposure immunization regimens, (d) to optimize dose regimens, vaccine formulation and immunization schedule demonstrated to be protective, based on the data from adequate animal models, and (e) to develop a feasibility plan to manufacture, formulate, and fill as single doses up to 25 million doses of rPA vaccine. Recently, significant changes have occurred in both the nature and degree of the threat posed by the use of infectious agents as weapons of biological warfare. The risk of using such weapons once appeared to be restricted to international conflicts involving small numbers of industrialized nations and an increasing number of developing countries. However, with the recent deliberate exposure of postal workers, other government employees and the American public at large to anthrax spores, there is an urgent need to devise appropriate and effective measures to protect U.S. citizens from the harmful effects of Bacillus anthracis spores used as instruments of terror. Among the strategies that might be considered to protect the American public from deliberate environmental exposure to B. anthracis spores, two are based on elicitation of protective immunity with vaccines. The first involves prior immunization with minimal doses of a vaccine known to generate significant and long-term protective immunity against inhalation spore challenge (pre- exposure vaccination). The second involves immunization, soon after aerosol exposure to spores and initiation of antibiotic prophylaxis, with a vaccine known to generate protective immunity relatively quickly after only a few immunizing doses (post-exposure vaccination). The latter would enable one to immunize at the time antibiotic therapy is begun so that a significant degree of protective immunity is present when antibiotic therapy is either completed or discontinued. In view of the events that have occurred since the national tragedy of September 11th, 2001, there is sufficient justification to warrant the rapid development, testing and licensure of a vaccine for both situations, ideally a single vaccine. Although a licensed anthrax vaccine is required for both pre-exposure prophylaxis and post-exposure immunization, the primary purpose of this procurement is development and production of a vaccine to protect the general US population against inhalation anthrax when administered in an immunization series of not more than three doses. Initially, the vaccine will be evaluated in both genders aged 18 55 years to facilitate comparison to currently licensed anthrax vaccine, but subsequent studies leading to licensure are expected to extend the range of ages in which it is indicated and develop optimal dose regimen and schedule for pre-exposure prophylaxis. Demonstration of protection in appropriate animal models of inhalation anthrax within two weeks of the completion of the primary series will serve as a surrogate measure of protective immunity in humans. Abundant preclinical evidence is available to indicate that immunization with native protective antigen (PA) and the recombinant protective antigen (rPA) of B. anthracis adsorbed to alum generates long-lasting protective immunity against inhalation spore challenge in animal models of the disease. This immunity is mediated by antibody directed at PA, and preclinical experience in animal models provides the basis for consideration of testing rPA in human clinical trials. The urgent nature of the current threat requires an accelerated pace of development, testing, approval and procurement of an emergency stockpile of vaccine. Although future anthrax vaccines may be formulated to include antigens other than rPA and adjuvants other than aluminum salts, these novel components are not requested because their consideration could complicate and delay approval of the vaccine sought in this solicitation. This solicitation is a request for proposals to develop, manufacture, characterize, and evaluate a pilot lot of B. anthracis recombinant protective antigen (rPA) vaccine and to supply the appropriate CMC information to support use of this product as an Investigations New Drug (IND) with the FDA. It is anticipated that one or more cost-reimbursement, completion type contracts will be awarded for Part A with incremental funding over a period of fifteen (15) months, Optional Part B, for which only candidate vaccine from Part A will be selected, will be funded for an additional twelve (12) months. The Government will select for Optional Part B the candidate vaccine that first meets the milestones and best meets the technical criteria listed in the Statement of Work. Progress will be measured against specific milestones that are listed in the Statement of Work, contract support for candidate vaccines that lag in meeting the milestones will be discontinued. RFP-NIH-NIAID-DMID-02-26 will be available electronically on or about April 22, 2002, and may be accessed through the Internet on the Contract Management Branch Homepage, located at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps at http://www.eps.gov/spg/HHS/NIH/NIAID/NIH-NIAID-DMID-02-26/SynopsisP.html. Please note that the RFP for this acquisition has been revised to include only the Work Statement, deliverable and reporting requirements, special requirements and mandatory qualification, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, Offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. Responses to this RFP will be due by 4:00 pm on Thursday, June 6, 2002. Any responsible Offeror may submit a proposal, which will be considered by the Government. Contracting Office Address: National Institutes of Health National Institutes of Allergy and Infectious Diseases Contract Management Branch 6700-B Rockledge Drive Room 2230, MSC 7612 Bethesda, MD, 20892-7612 Point of Contact: Phillip Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, E-Mail ph23k@nih.gov This announcement does not commit the Government to award a contract. No collect calls will be accepted.

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