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REDS-II RFP

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REQUEST FOR PROPOSALS (RFP)
Retrovirus Epidemiology Donor Study-II (REDS-II):
Refinement and Manufacture of HIV EIA and Rapid Tests for Use in
HIV Vaccine Clinical Trials

Table of Contents

Overview

For the Retrovirus Epidemiology Donor Study-II (REDS-II), Westat is seeking proposals from infectious disease test developers/manufacturers for:

  • Refining, assembling, validating, and obtaining Food and Drug Administration (FDA) approval for HIV-SELECTEST enzyme-linked immuno-absorbent assay (EIA) kits for distribution to national and international laboratories conducting Phase I to III HIV-1 vaccine trials, and
  • Developing, refining, assembling, validating, and obtaining FDA approval for a Rapid HIV-1 Antibody Test based on the HIV SELECTEST, which is being developed by the FDA.

For both tasks, work will be conducted in two stages to include preclinical studies/test refinement and clinical trials/test validation.

The work will be performed as a component of the National Heart, Lung, and Blood Institute (NHLBI) REDS-II, and thus will be conducted under its sponsorship and that of the National Institute of Allergy and Infectious Disease (NIAID).

One award will be made to a U.S. infectious disease test developer/manufacturer for a period of 3 years. This acquisition has been designated as full and open competition.

Minimum requirements from contractors considered responsive to this RFP must include:

  • Demonstrated experience in relevant test development and manufacturing areas.
  • Stated agreement to abide with the REDS-II Publications Committee publication policies and procedures outlined in the RFP.

HIV-SELECTEST EIA Kit Development and Manufacture

Contractors will be responsible for preparing, purifying, and testing the HIV-1 synthetic peptides to be used in the HIV-SELECTEST. There are four peptide sequences: two for Gag p6 and two for gp41 EIA.

Verification of the specificity, sensitivity, and reproducibility of the EIA must be conducted using:

  • Commercially available serological reference panels,
  • Clinical specimens from HIV-1 vaccine trials,
  • Specimens from studies deemed as false positives or indeterminate based on FDA-licensed serological kits and Western Blot kits,
  • Specimens from HIV-1 epidemiological evaluations, and
  • Other studies with infectious agents relevant to HIV-1 infection.

Preclinical sensitivity and specificity study requirements for an Investigational Device Exemption (IDE) will be provided. Comparison and stability studies to define the sensitivity, specificity, reproducibility, and robustness of the HIV-SELECTEST EIA in detecting acute HIV-1 infections will be required.

For clinical trials/test validation, the contractor will be expected to ship and distribute kits to up to 20 national and international clinical laboratories supporting HIV-1 vaccine trials. (Approximately 5,000 EIA kits will be manufactured and shipped to designated study sites.) The contractor shall submit an IDE application to the FDA.

The laboratories will conduct clinical testing of specimens obtained from Phase I to III clinical trials. Also, in-house parallel testing of 10% to 15% of these specimens by the clinical laboratories is required for:

  • Quality assurance/quality control compliance,
  • Assessment of results variability across laboratories,
  • Variability across kit lots, and
  • Kit stability.

Plans for the Rapid HIV-1 Antibody Test should include refinement of the assay. Since this assay is being developed by FDA scientists as a second generation HIV-SELECTEST, the technology will be transferred to the contractor following the award.

Comparison Studies Requirement

Contractors will be required to compare the performances of the HIV-SELECTEST EIA, the Rapid HIV-1 Antibody Test, and current FDA-approved HIV-1 tests. These comparison studies will test clinical specimens in parallel with participating regional and primary diagnostic testing laboratories supporting HIV-1 clinical trials.

To conduct the comparative studies, the contractor must:

  • Develop an external quality assurance program containing standard proficiency testing panels,
  • Produce 420,000 HIV-1 Rapid Tests, and
  • Submit an IDE application to the FDA.

RFP and Deadlines

Letters of Intent

  • Letters of Intent forms are available here: Word version Word Icon   PDF version PDF Icon
  • Address all Letters of Intent to Russell Walker via fax (301-738-3500) or email (REDSIIRFP@westat.com).
  • Completed Letters of Intent are due Monday, May 21, 2007.

Please note: This deadline to receive Letters of Intent is not binding. If you are planning to submit a response to this request for proposal, please contact Westat and confirm your intentions as soon as possible. You may submit your Letter of Intent up until the due date of the proposal (Monday, July 9, 2007).

Questions

Proposals

  • The full RFP is available here: Word version Word Icon   PDF version PDF Icon
  • RFP Amendment #1, dated June 8, 2007, is available here: PDF version PDF Icon
  • Proposals are due Monday, July 9, 2007, by 3:00 p.m. Eastern Daylight Time.

Submission Instructions

Submission instructions for the RFP are included in Section A of the RFP and in Section L, Attachment 3.

Cost Proposal

Submission instructions for cost proposals are included in Section L, Attachment 3. Additional instruction on preparing a cost proposal are available at http://oamp.od.nih.gov/contracts/BUSCOST.HTM. Eleven Excel worksheets are provided, the first of which contains instructions. You must save the spreadsheet before you enter information.

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