SOLICITATION NOTICE
A -- GLP Safety Testing Of Developed Vaccines - S09-159 RFP Cover Sheet
- Notice Date
- 5/28/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S09-159
- Archive Date
- 7/31/2009
- Point of Contact
- Howard Souder, Jr., Phone: 301-846-5096
- E-Mail Address
-
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This document contains terms/conditions, as well as the SOW - Attachment 1. S09-159 RFP Cover Sheet is required to be included with any offeror(s) response. This document contains explicit instructions. This Statement of Work is contained in Attachment 1 of the RFP GLP Safety Testing of Vaccines Developed by Vaccine Research Center (VRC) Manufactured for Clinical Trial Use Background The mission of the Vaccine Research Center (VRC) is to facilitate the development and testing of new vaccine strategies. Investigators at the VRC are working to develop a number of different vaccine product candidates. The materials to be tested for this requirement are investigational vaccines containing genes for infectious diseases, including HIV, influenza, filoviruses (Ebola and Marburg) and other emerging infections. These vaccines may be DNA plasmids, viral vectors, or other novel vaccine platform technologies. The vaccines are not pathogenic but some products may require handling in biosafety level-2 (BSL-2) containment. The Subcontractor shall be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and help develop and finalize protocols with VRC to perform FDA mandated safety testing and characterization of clinical grade investigational vaccines. The tests must be conducted in accordance with Good Laboratory Practices (GLP) standards (21CFR, Part 58). Testing The materials to be tested for this requirement are investigational vaccines containing genes for infectious diseases including HIV, influenza, filoviruses (Ebola and Marburg) and other emerging infections. These vaccines may be DNA plasmids, viral vectors, or other novel vaccine platform technologies. These will be tested in the Single-Dose BioDistribution and Repeated-Dose Toxicology Studies listed below. There may be additional (Integration) study testing required as well. For each test, one or more Test Article group(s) of animals is required for the vaccine and one group is required for a Control. The assays required will be performed using rabbits or other suitable animals. Single-dose BioDistribution Studies Perform testing according to Standard Operating Procedures (SOP) unless otherwise noted, using polymerase chain reaction (PCR) or a method of similar sensitivity to determine whether vaccines injected distribute to an/or persist in various tissues over a period of time in rabbits or other suitable animals. Repeated-dose Toxicology Studies Perform testing according to SOP to measure the toxicity of the vaccines when delivered in a manner similar to that proposed for clinical use. Toxicity is measured by performing biochemical tests on major organs and tissues and other in-life parameters and gross pathology and histological analysis. Integration Studies Perform testing according to SOP in order to prepare tissues for measurement of the integration of injected vaccines into the chromosomal DNA of tissues of injected rabbits or other animals as may be required by the VRC to fulfill regulatory requirements. The tasks include: Perform GLP safety studies suitable for submission to the FDA for support of an IND application. o Confirm AAALAC accreditation prior to initiating the study o Work with the VRC to develop and finalize protocols. The VRC and the Subcontractor will sign off on the protocol and retain a copy o Purchase and quarantine of suitable animals as specified in the protocol o Housing of animals (1 animal per cage), test animals and control animals in separate rooms o Administer injections of vaccine as directed in study protocol o With VRC's help, acquire and become trained to use Biojector and any other specialized injection devices o Provide clinical evaluation and assess other measurements of health as specified in the protocol o Euthanize animals and perform a gross necropsy in accordance with study protocol o Collect blood and tissue from animals; send aliquot of blood to VRC for immune analysis and send tissues for other analysis as directed by VRC o Run clinical chemistry and hematology tests as specified in protocol o Run biodistribution studies as specified in protocol o Analyze histopathology of preserved tissues as specified in the protocol o Perform statistical analyses of test results and provide updated historical data for gender-matched unimmunized or placebo-controlled animals for comparison as specified by the protocol o Audit test results o As appropriate, investigate deviations of the protocol, procedures, or unexpected test results (e.g. moribund or found-dead animals) and report such investigations to VRC staff in a timely fashion. o Provide unaudited interim, unaudited, and audited, signed final report as indicated in the protocol • Interim clinical observations and measurements via email on a bi-weekly basis as indicated in the protocol. Interim ("unaudited") report transmitted electronically to Project Coordinator and the VRC Project Lead (contact information listed below) • Final report - One hard copy of this report can be sent to the VRC Project Lead and an electronic pdf version can be provided to Project Coordinator. Deliverables: The Subcontractor shall submit the following deliverables for each test: o Provide a timeline that summarizes the approximate time required to complete each key step (protocol preparation, in-life portion, necropsy and other post-life procedures, preparation of draft report, preparation of final report). o Bi-weekly interim ("unaudited") report which include, data updates during the course of the testing, & health/welfare of study animals. o Reports of investigations, if applicable. o Final report. o The Interim report should be transmitted electronically to the individuals stated in each resulting Task Order. o One hard copy and an electronic copy of the final report should be provided to the individuals designated in each resulting Task Order. Meetings In addition to kick off meetings at the onset of each project, it is anticipated that there will be an initial facility audit, on performed prior to awarding the contract to evaluate the SOPs used, periodic site visits to the Subcontactor(s) facility(ies) (e.g., on days when major study procedures are occurring such as dosing or necropsy) and additional meetings that shall occur as needed to keep the SAIC-Frederick, Inc. COTR and VRC Project Officer informed regarding the progress of the project. These visits and meetings may also include lower-tier Subcontractors if applicable. In the absence of formal meetings, contact with the Subcontractor shall occur via phone, facsimile, or email. Subcontractor Requirements: In order to be considered a viable candidate, Subcontractors must: • Provide proof of current AAALAC accreditation • Allow the VRC to conduct an initial audit of facilities to evaluate the SOP's being used. • Provide a copy of SOP's for consideration in accomplishing the tasks and providing the deliverables outlined. • Identify level of expertise in specialized injection devices, such as Biojector, and be willing for the VRC to provide/oversee training on such devices. Example - Table of Contents: COMPLIANCE STATEMENT QUALITY ASSURANCE STATEMENT SIGNATURE PAGE SUMMARY STUDY PERSONNEL AND TEST SITES STUDY TIMETABLE INTRODUCTION METHODS AND MATERIALS Test and Control Articles Test Animals and Husbandry Experimental Design Observations Termination and Necropsy Statistical Analyses Record Retention RESULTS Stability Data Dose Formulation Analysis Animal Disposition and Observations Body Weight and Body Weight Changes Biodistribution or Toxicology Data CONCLUSION ABBREVIATIONS TABLES Summary of Animal Disposition and Clinical Observations Summary of Cageside Observations Summary of Body Weights Summary of Body Weight Changes APPENDICES Certificate of Analysis and Stability Data Dose Formulation Analysis Individual Animal Disposition and Clinical Observations Individual Cageside Observations Individual Body Weights Individual Body Weight Changes Biodistribution Report Protocol, Amendments, and Deviations
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S09-159/listing.html)
- Place of Performance
- Address: At vendor(s) location, pending approval of facility audit and Subcontract Award., United States
- Record
- SN01829594-W 20090530/090528235458-8bffab005d68d09b6653e9df5e0d5bf5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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