Loren Data's SAM Daily™

FBO DAILY ISSUE OF JANUARY 09, 2002 FBO #0038
PRESOLICITATION NOTICE

A -- Operation of Facility for the Testing of Malaria Vaccines in Adult Human Subjects

Notice Date

1/7/2002
 

Notice Type

Presolicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700-B Rockledge Drive, MSC 7612 Room 2230, Bethesda, MD, 20892-7612
 

ZIP Code

20892-7612
 

Solicitation Number

RFP-NIH-NIAID-DIR-03-03
 

Response Due

4/22/2002
 

Archive Date

5/7/2002
 

Point of Contact

Thomas Hastings, Contracting Officer, Phone 301-496-0194, Fax 301-402-0972, - Lawrence Butler, Contracting Officer, Phone 301-496-0192, Fax 301-402-0972,
 

E-Mail Address

ph23k@nih.gov, lb13t@nih.gov
 

Description

The purpose of this contract is conduct Phase I malaria vaccine trials in health adult volunteers to determine the best compromise between dose, immune response and frequency of adverse events prior to testing combinations in Phase I and Phase II studies in malaria endemic areas. The Malaria Vaccine Development Unit (MVDU), NIAID, has a mandate to develop the process for manufacture 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 I safety and immunogenicity trials in the USA and undertake Phase I and Phase II studies in populations endemic for malaria. The MVDU program has resulted in six antigens that either have or are likely in the near future to be prepared as clinical grade antigens suitable for Phase I 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 I 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. Mandatory Facilities Criteria: 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 primarily 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 is secondarily to facilitate regular meetings of the Project Officer and other NIAID with the Offerer. The Government scientists must also have ready access to examine the volunteers and to receive labile clinical specimens obtained from these volunteers. It is anticipated that a single cost-reimbursement, completion type contract will be awarded with incremental funding over a period of seven (7) years. RFP-NIH-NIAID-DIR-03-03 will be available electronically on or about January 22, 2002, and may be accessed through the Internet on the Contract Management Branch Homepage, located at http://www.niaid.nih.gov/contract/. 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 Monday, April 22, 2002. Any responsible Offeror may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted.
 

Place of Performance

Address: To Be Determined

Zip Code: TBD

Country: TBD
 

Record

SN20020109/00012097-020108092251 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(will not be valid after Archive Date)

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