SOURCES SOUGHT
A -- Chlamydia Trachomatis Vaccine Safety and Efficacy Evaluation in Nonhuman Primates
- Notice Date
- 11/4/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID-RDSS-14-NIHAI2014003
- Archive Date
- 11/23/2013
- Point of Contact
- Courtney A Nichols, Phone: 3014513689, George W Kennedy, Phone: (301) 451-2607
- E-Mail Address
-
courtney.nichols@nih.gov, kennedyg@mail.nih.gov
(courtney.nichols@nih.gov, kennedyg@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION/SYNOPSIS This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential R & D requirement. BACKGROUND This National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) project is for work related to the contract below: -Topical Microbicide Safety and Efficacy Evaluation in Nonhuman Primates, University of Washington (Contract HHSN266200700013C) This contract was awarded on a competitive basis for a seven year period in 2007 with the objective of developing topical microbicides aimed at the prevention and control of sexually transmitted infections (STIs) through pre-clinical testing in nonhuman primates (NHPs). The period of performance is May 31, 2007 to May 30, 2014. The value of the contract is $11,062,715. When potential contractors were solicited in 2007, the NIAID received two proposals in response, resulting in the contract award to the University of Washington. During the course of this contract, there have been ten microbicide products and barrier devices tested in thirteen studies. These products represent a range of types from viscous gels to delivery devices to administer compounds to the vaginal and rectal compartments. These product evaluations include safety parameters, documentation of adverse events, and in a subset of products, evaluation of efficacy. Currently, the University of Washington is conducting a Chlamydia vaccine study in female pigtailed macaques. This study includes pathogenesis and treatment studies of Chlamydia trachomatis, evaluation of immunity to heterotypic and homotypic chlamydial strains, and studies of pelvic inflammatory disease evaluating the presence and extent of cervicitis, the effects of antimicrobial and anti-inflammatory agents on the course of PID, the characteristics of the immune response in the pigtailed macaque, potential vaccine candidates, and the persistence of infection in the upper reproductive tract. Through expiration of the current contract, the University of Washington will complete the pathogenesis study on their colony of female pigtailed macaques to determine the extent to which the wild type strain of Chlamydia D/LC/P+ with an intact CT135 gene and plasmid can infect this NHP causing lower and upper reproductive tract infection, in relation to the infection-incompetent strain D/EC/P- with a disrupted CT135 gene and plasmid for comparison. These strains were developed at the Rocky Mountain Laboratories of NIAID wherein the infectious wild type parent strain, D/LC/P+ with an intact CT135 gene and plasmid, was genetically manipulated to make the Chlamydia vaccine strain, D/EC/P- with a disrupted CT135 gene and plasmid, therefore making it infection incompetent. Upon completion of the pathogenesis study, testing for the efficacy of the Chlamydia vaccine can begin. As such, the NIAID intends to award a contract to the University of Washington for the efficacy study portion of this vaccine study as it cannot be performed as part of the existing severable contract and requires completion through the existing monkey colony. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID. PURPOSE AND OBJECTIVES The purpose of this Research and Development Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R & D Sources Sought Notice, the NIAID may issue a Request for Proposal (RFP) if it deems this necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to continue development of a Chlamydia STD vaccine by performing an efficacy study in pigtailed macaques. This efficacy study follows the pathogenesis study completed under the current contract with University of Washington. The NIAID seeks to test this vaccine for efficacy using the female pigtailed macaque at the University of Washington against sexually transmitted Chlamydia D/LC/P+ with an intact CT135 gene and plasmid to determine if it can proceed to a phase 1 clinical trial. PROJECT REQUIREMENTS The NIAID intends to solicit the University of Washington to perform an efficacy study, the next step in the development of a Chlamydia vaccine following the pathogenesis study currently being performed in the female pigtailed macaque colony at the University of Washington. This work will consist of a vaccine efficacy study on two sets of female pig-tailed macaques over an 8 month period. The study will begin with a series of baseline tests and procedures to evaluate the animal subjects including inspection of lower and upper reproductive tract tissue, blood draws for antibody response, cervical swabs for cytokine level detection in the vagina, evaluation of the cervical and vaginal tissues via colposcopy, and any other preliminary tests or procedures necessary. Following these initial evaluations, one set of animals will receive a placebo and the other will receive the infection-incompetent strain D/EC/P- with a disrupted CT135 gene and plasmid, both administered vaginally at designated intervals over the course of 14 weeks at which point infection levels will be determined. Both animal groups will then be re-infected with the wild type strain only and evaluated for 14 weeks with weekly or biweekly testing and procedures. The results of the ongoing tests will be used to document immune responses both locally in the vagina and systemically to determine infection status over the course of the study. Success of the vaccine will be determined by the antibody response to the vaccine and the presence or absence of lower reproductive tract infection. The female pigtailed macaque (Macaca nemestrina) is required for this project because of its similarities to the human female reproductive tract. The pigtailed macaque has a 28-30 day menstrual cycle. The anatomy and physiology of the reproductive system are well characterized and documented in the literature and the macaque is naturally susceptible to the human biovars of C. trachomatis without the need for pretreatment with exogenous hormones to initiate or sustain a chlamydial infection. In order to complete this project, colposcopy examination of the pigtailed macaque to evaluate for signs of infection is necessary. This is a minimally invasive procedure allowing the practitioner to view the cervix and vaginal vault structures. It is used clinically to identify infections and its effects including tissue damage. This procedure requires a colposcope appropriate for use on pig-tailed macaques and equipped with a digital camera to capture changes in animal tissue following development of lower reproductive tract disease or lack thereof. The benefits of using this method are myriad and vital to the completion of this project. Because it is a minimally invasive procedure, this method causes little or no discomfort meaning faster recovery time, quicker return to normal activity and no internal scarring. The skill level needed for proper interpretation of colposcopic images is critical throughout the study, as errors could lead to misdiagnosis, incorrect data, and ultimately inaccurate endpoints, negatively impacting both timing and overall cost of the project. The contractor will be responsible for performing colposcopic examinations of anesthetized female pigtailed macaques to check for signs of infection as well as monitoring and scoring upper reproductive tract tissues viewed through colposcopy digital imaging. ANTICIPATED PERIOD OF PERFORMANCE June 1, 2014 - March 31, 2015 CAPABILITY STATEMENT/INFORMATION SOUGHT Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors' facilities, qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: 1.Access to a colony of female pigtailed macaques, including one set that has been exposed to the wild type parent strain of Chlamydia D/LC/P+ with the intact CT135 gene and plasmid and another that has been exposed to the Chlamydial vaccine strain D/EC/P- with the disrupted CT135 gene and plasmid. 2.Experience working with the infectious wild type parent strain of Chlamydia D/LC/P+ with the intact CT135 gene and plasmid and the Chlamydial vaccine strain, D/EC/P- with the disrupted CT135 gene and plasmid, including knowledge of proper storage and handling of these strains, experience defrosting and preparing these strains and familiarity with Chlamydial biosafety handling requirements in a laboratory setting involving NHPs. 3.Experience working with female pig-tailed macaques demonstrating a high level of expertise in utilizing this animal as a model of the female reproductive tract in order to study STIs focusing on experience doing the following: a.Inspecting lower and upper reproductive tract tissue b.Conducting blood draws for antibody response c.Taking cervical swabs for cytokine level detection in the vagina d.Performing colposcopies and interpreting digital images to check for signs of infection e.Monitoring and scoring upper reproductive tract tissues viewed through colposcopy digital imaging f.Vaginal administration of wild type Chlamydia and infection-incompetent strains g.Mapping of immune responses both locally in the vagina and systemically to determine infection status 4.Access to equipment, expertise and facilities for performing the procedures listed above with particular focus on conducting colposcopies on female pig-tailed macaques. Colposcopy equipment must be appropriate for use in pigtailed macaques and equipped with a digital camera capable of capturing images of animal tissue in the lower reproductive tract. Sources are expected to have the necessary skills and tools to meet the requirements of this project. Capability statements must include the following: 1.Respondents' DUNS number, organization name, address, and point of contact. 2.Respondents' opinions about the difficulty and/or feasibility of the potential proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. 3.Information regarding respondents' a.Staff expertise, including their availability, experience, and formal or other training b.Current in-house capability and capacity to perform the work c.Prior completed projects of similar nature 4.Any other information that may be helpful in developing or finalizing the acquisition requirements. **Capability statements should be submitted by email using the contact information above. Submissions should be in PDF format, no smaller than 10 pt. font and 10 pages or less.** DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID-RDSS-14-NIHAI2014003/listing.html)
- Record
- SN03227365-W 20131106/131105000204-e09133248d5d47c3154b79fc88cbc765 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |