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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