RFP ANNOUNCEMENT: OPERATION OF A FACILITY FOR THE TESTING OF MALARIA VACCINES 
IN ADULT HUMAN SUBJECTS - NIH-NIAID-DIR-04-01

RELEASE DATE:  September 2, 2003

NOTICE: NOT-AI-03-054

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

RECEIPT DATE:  December 16, 2003

DESCRIPTION

The Malaria Vaccine Development Unit (MVDU), NIAID, has a mandate to develop 
the process for manufacture of pilot lots of clinical grade material of 
promising malaria vaccine candidate antigens; to produce clinical grade 
prototype malaria vaccines through collaborations or contract manufacture; to 
undertake Phase 1 safety and immunogenicity trials in the USA and undertake 
Phase 1 and Phase 2 studies in populations endemic for malaria. The MVDU 
program has resulted in eight antigens that either have or are likely in the 
near future to be prepared as clinical grade antigens suitable for Phase 1 
trials. Several other antigens are at an earlier stage of development and 
some of these are likely to become available during the contract period.  
Depending on the results on Phase 1 trials of individual antigen and adjuvant 
combinations, it is expected that these antigens will progress to field 
testing as three combination vaccines, a mixture of four Plasmodium 
falciparum blood stage antigens, a mixture of two P. falciparum sexual stage 
antigens and a mixture of the same two P. falciparum sexual stage antigens 
with two P. vivax sexual stage antigens. These combinations must be tested in 
Phase I studies in the USA before they can be taken to an endemic area.  The 
following mandatory qualification criteria establishes a condition that MUST 
be met at the time of receipt of initial proposals by the Contracting Officer 
in order for the proposal to be considered any further for award:

The Offeror shall demonstrate that their facility where vaccines will be 
formulated and volunteers vaccinated is approximately one hour travel, and no 
more than 2 hours under heavy traffic conditions from the MVDU unit at 
Rockville MD. This requirement is to allow, if necessary, vaccines prepared 
as "point of injection formulations" either at the MVDU facility or at the 
contractor's facility to undergo QC procedures at MVDU after formulation and 
prior to injection, while still meeting a 4 hour limit on the time from 
formulation to injection. This travel limit will also facilitate regular 
meetings between the Project Officer and other NIAID Investigators and the 
Offeror. The Government scientists must also have ready access to examine the 
volunteers and to receive labile clinical specimens (e.g. whole blood 
samples) obtained from these volunteers.

The Government contemplates awarding one (1) cost-reimbursement type contract 
for accomplishing the tasks outlined in the Statement of Work for a period of 
seven (7) years.  RFP NIH-NIAID-DIR-04-01 will be available electronically on 
or about September 4, 2003, and may be accessed through the NIAID Contract 
Management Branch (CMB) Home Page at http://www.niaid.nih.gov/contract and 
will be posted on FedBizOpps at http://www.fedbizopps.gov/. Responses to this 
RFP will be due on December 16, 2003.  See Numbered Note 26.  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.  

Contracting Office Address:

Department of Health and Human Services
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:

Donald Collie, Contract Specialist, Phone 301-496-0992, Fax 301-480-5253, 
Email dc128b@nih.gov
Thomas Hastings, Contracting Officer, Phone 301-496-0194; Fax 301-480-5253; 
Email ph23k@nih.gov

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