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Release Date:  June 5, 2002


National Institute of Allergy and Infectious Diseases (NIAID)

Receipt Date:  September 16, 2002


The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the National 
Institute of Allergy and Infectious Diseases (NIAID), National Institutes of 
Health (NIH), supports a comprehensive portfolio of grant and contract 
resources to discover, develop and test potential vaccines to prevent and 
treat infections caused by Human Immunodeficiency Virus-1 (HIV-1).

The purpose of this contract is to support acquisition of specific datasets 
by studying the immune responses of individuals infected with non-clade B 
HIV-1 at one or more international location(s). These datasets include: a) 
DNA-based molecular HLA class I and II typing of selected HIV seropositive 
and seronegative populations at existing or proposed international vaccine 
trial sites; b) characterization of cellular immune responses and the mapping 
of CTL epitopes and helper epitopes that are restricted by common HLA types; 
c) measurement of neutralizing antibody responses; d) identification, 
characterization and sequencing of circulating HIV-clade variants; and e) 
establishment of a database of HLA-types, associated T cell epitopes, 
antibody responses, and viral variants.  

The "HLA Typing and Epitope Mapping to Guide Vaccine Design" initiative was 
first competed in 2000. This competition attracted a high level of interest 
and quality of Offerors. One award, N01-AI-15442, with Massachusetts General 
Hospital was instituted in May 2001. The emphasis in N01-AI-15442 is 
measuring HIV-specific T cell immune responses and performing viral 
sequencing in HIV-1 clade B-infected non-Caucasian populations in the 
Americas, and in non clade-B infected populations in South Africa. The 
purpose of this initiative is to expand acquisition of the datasets described 
above into additional, new, international sites.

The clinical research organization must: 1) Establish a research and 
administrative team that includes all expertise needed to: select and acquire 
HIV+ and HIV- human specimens; perform DNA-based molecular HLA class I and II 
typing in selected seropositive and seronegative populations; perform an 
array of immunologic assays, in particular CD8+ and CD4+ T lymphocyte 
cellular assays; identify CTL and immunodominant T helper epitopes and their 
respective HLA-restricting elements in HIV-infected individuals; measure 
neutralizing antibody responses in HIV-infected people; perform sequence 
analysis of the HIV viral variants in the geographic location(s) of the cohorts 
to be vaccinated; and establish a database of the acquired immunogenetic, 
immunologic and virologic information.  2) Select, secure, receive, catalog, 
process and store samples from uninfected and HIV-infected individuals at 
international sites that are very likely to conduct future HIV-1 vaccine trials. 
Sampling may include: whole blood, viably cryopreserved blood mononuclear cells, 
serum, other tissues or body fluids, and virus culture supernatants from. The 
Contractor shall arrange for samples to be shipped from the supplier directly 
to the Contractor or to a central sample processing facility. The handling and 
transportation of all samples under this contract shall be in accordance with 
all applicable local, state, Federal and international regulations including 
health and safety standards. 

It is anticipated that the period of performance for this contract will be a 
total of  five (5) years beginning on or about 05/08/2003.  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. No facsimile transmissions will be accepted.
RFP-NIH-NIAID-DAIDS-03-13 will be available electronically on or about May 
30, 2002, may be accessed through the NIAID Contract Management Branch (CMB) 
Home Page at http://www.niaid.nih.gov/contract and will be posted on 

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: 

Scott Drega
Contract Specialist
Phone 301-496-6424
Fax 301-480-5253
Email sd222q@nih.gov

Paul D. McFarlane
Senior Contracting Officer
Phone 301-496-0349
Fax 301-402-0972
Email pm24v@nih.gov

This announcement does not commit the Government to award a contract. No 
collect calls will be accepted.

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