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Chlamydia Trachomatis Vaccine Safety and Efficacy Evaluation in Nonhuman Primates

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NIAID-DMID-NIHAI2014003Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The National Institute of Allergy and Infectious Diseases (NIAID) plans to award a sole source contract to the University of Washington to conduct a safety and efficacy study of a Chlamydia trachomatis vaccine using female pigtail macaques. This effort is a continuation of the previous contract related to topical microbicide evaluation and follows an ongoing pathogenesis study at the same institution. The vaccine will be tested against a specific sexually transmitted strain of Chlamydia with an intact CT135 gene and plasmid to assess its potential for progression to a phase 1 clinical trial. The University of Washington is uniquely qualified for this work due to its possession of the necessary facilities, expertise, and access to the macaques, as well as its continuity of specimen sources, which helps avoid duplication of costs and supports the government's interest under FAR 6.302-1 for a non-competitive procurement. The contract is expected to be a cost-type completion award with a nine-month performance period. While this announcement does not constitute a request for proposals, interested and responsible parties may submit capability statements or quotations that will be considered. The official request for proposals was anticipated to be issued in late February 2014. Points of contact for the contract include a Contract Specialist and Contracting Officer at the NIH, with detailed information provided to facilitate communication and potential engagement. The initiative is aligned with efforts to advance vaccine development for sexually transmitted infections using nonhuman primate models.

General Info

NIAID awards University of Washington sole source contract for Chlamydia vaccine macaque study.

Agency

N/A

NAICS

541711 - Research and Development in Biotechnology

Place of Performance

Not specified

Set-Aside

NONE

Documents

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Timeline

PhasePresolicitation

PostedFeb 10

Presolicitation

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Organization & Contact Information

AgencyN/A

Contacts2 people available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Courtney A NicholsContract Specialist

contact@example.gov

+1 (555) 000-0000

George KennedyContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

The NIAID intends to solicit a sole source contract with the University of Washington to perform a Chlamydia trachomatis vaccine safety and efficacy study. This contract is a follow-on to the Topical Microbicide Safety and Efficacy Evaluation in Nonhuman Primates contract (HHSN266200700013C). The purpose of this follow-on contract is to continue development of a Chlamydia STD vaccine by performing an efficacy study in pigtail macaques. This efficacy study follows the pathogenesis study currently being conducted under the contract with University of Washington. The NIAID seeks to test this vaccine for efficacy using the female pigtail macaque against sexually transmitted Chlamydia D/LC/P+ with an intact CT135 gene and plasmid to determine if a phase 1 clinical trial is appropriate. The University of Washington possesses the facilities, resources, expertise and access to pigtail macaques that make it uniquely qualified to perform this work. Additionally, the safety and efficacy study must be performed on specimens from the same source as those used for the pathogenesis study. Since the pathogenesis study is already underway at University of Washington, awarding the contract to another source would result in substantial duplication of costs. This procurement is being conducted in accordance with FAR 6.302-1. The unique services University of Washington can provide make it the only responsible source capable of supplying the services required by the NIAID. Award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. NIAID anticipates awarding a cost-type completion contract as a result of this announcement with a performance period of 9 months. This is not a request for proposals, proposal abstracts, or quotations and does not commit the Government to any contractual agreement. A Research and Development Sources Sought Notice was posted on November 4, 2013 as HHSN-NIH-NIAID-RDSS-14-NIHAI2014003. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The RFP will be available on or about February 25, 2014. Interested parties may contact the points of contact referenced in this announcement.