R -- VALIDATION AND APPLICATION OF A DISTAL GASTROINTESTINAL TRACT EXPLANT MODEL FOR SAFETY AND EFFICACY TESTING OF POTENTIAL HIV-1 TOPICAL

Notice Date

May 3, 2001

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146

ZIP Code

30341-4146

Solicitation Number

2001-Q-00094

Response Due

May 18, 2001

Point of Contact

Phillip Green, Contract Specialist, Phone (770)488-2638, Fax (770)488-2670, Email PGreen@CDC.GOV

E-Mail Address

Phillip Green (PGreen@CDC.GOV)

Description

The Centers for Disease Control and Prevention intends to enter into negotiation for a sole source purchase order under Simplified Acquisition Procedures with Department of Infectious Diseases, St George's Hospital Medical School, Cranmer Terrace, Tooting, London, SW17 ORE, United Kingdom, as follows A. BACKGROUND AND NEED The purpose of this project is to implement laboratory protocols for in-vitro evaluation of the safety and efficacy against HIV-1 infection of candidate topical microbicides when applied to distal gastrointestinal (GI) tissues. Despite gains in condom use over the past 20 years, HIV transmission continues worldwide. This fact reinforces the importance of identifying additional effective prevention methods Microbicides, chemical compounds which can be applied topically and which inactivate or kill HIV, have been identified in laboratory and animal studies. The findings of initial studies of vaginal application have sparked interest in the potential of microbicides to reduce HIV transmission when applied rectally by women or MSM. Vaginal explant models have been developed by several investigators and have yielded useful data on the in-vitro safety and efficacy of several microbicides. To date, no distal GI explant model has been validated for microbicide research. The methods to evaluate safety of nonoxynol-9 when rectally applied in humans are still being developed and validated and have yielded conflicting results, reinforcing the need for an in-vitro model. SPECIFIC TASKS TO BE PERFORMED: The vendor shall provide labor, technology, materials, drugs, supplies, equipment, transportation, and other incidentals necessary to conduct in-vitro assays evaluating the safety and effectiveness of microbicides applied to distal GI explants and tissues. In addition, the vendor will cover transportation costs (COD) for specimens or microbicides to be shipped to their facility for analysis. Task 1. Extablish a validated adultdistal GI tissue explant assay The vendor shall establish access to healthy human distal GI tissue specimens (with local ethics committee approval). Such specimens must be unlinked to an identifiable person. An explant culture system shall be established with tissue survival and integrity verified for sufficient duration to complete microbicide assays (approximately 7-10 days). The vendor shall submit to the Project Officer all assay evaluation data by hard copy and by disk or electronic transfer at the conclusion of explant validation testing. Task 2.Obtain access to sufficient quantities of microbicides for testingThe vendor shall consult with the Project Officer to determine the four (4) to six (6) microbicides to be tested. The vendor, with the assistance of the CDC Project Officer if necessary, shall obtain sufficent quantities of these microbicides for testing and complete any paperwork required by the manufacturer or others..The vendor shall submit to the Project Officers, hard copies of any written agreements. Task 3 The vendor shall, using protocols agreed upon with the Project Officer, conduct the following assays for the selected microbicides: Evaluate gross toxicity of microbicides when applied to distal GI explants by visual inspection and histopathology analyses. Evaluate the effects of microbicides on contituent tissue cell-types by histochemical analyses. Evaluate the effects of microbicides on proinflammatory cytokines by cDNA microarray or other techniques. Evaluate the ability of microbicides to block HIV-1 infection (using lab-adapted and primary viral isolates) by standard virologic assays. DELIVERABLES: Within 30 days of the award of the purchase order, the vendor shall provide the Project Officer with a written copy of the local Ethics Committee approval to obtain distal GI tissue specimens. Within 120 days of the award of the purchase order, the vendor shall provide the Project Officer by hard copy and by disk or electronic transfer the results of validation studies of the distal GI explant culture system. The vendor will confirm to the Project Officer in writing, access to supplies of the selected microbicides. Within 1 year of the award of the purchase order, the vendor will provide by hard copy and by disk or electronic transfer all assay evaluation results from completion of the assays listed above in Task 3 for each of the the four (4) to six (6) microbicides selected. The period of performance is from the effective date of the contract through aperiod of 12-months. ADDITIONAL INFORMATION: The vendor shall demonstrate previous success with: A. the development and validation of GI or vaginal explant culture systems, B. laboratory research with replication-competent HIV-1 virus, C. histochemical and cytokine assays 2. The vendor shall not use any information derived from the assays perfomed with CDC funds for presentation, publication, or promotional purposes without written permission from the CDC Project Officer. 3. The government reserves the right to terminate the contract if: any breach of confidentiality or unapproved use of information derived from the assays occurs or, if assays are not conducted or reports and results are not received in a timely fashion. The anticipated date of award of this procurement is May May 22, 2001. Interested parties should sumbmit a work and financial plan in sufficient detail to enable the Government to make a best value detrmination of technicalcapability,understanding of the project , and finacial reasonableness. This is a simplified acquisition with an estimated value of less than $100,000.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=2001-Q-00094&L=2965)

Record

Loren Data Corp. 20010507/RSOL005.HTM (D-123 SN50L1I1)