Preclinical Master Contract
NIAID has placed a high priority on the development of safe and effective HIV vaccines for worldwide evaluation and use. A Preclinical Master Contract has been awarded to aid the preclinical development of promising vaccine candidates from the research laboratory to the clinic. This contract offers an array of resources to facilitate development of a promising candidate into a testable product. Resources are available to accomplish three basic functions:
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Manufacture GMP pilot lots of vaccine for testing in humans, or GLP/reagent grade vaccine for testing in nonhuman primates |
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Perform tests for safety, immunogenicity and other preclinical testing of GMP produced candidates |
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Preparation of FDA submissions leading up to human trials |
Specific vaccines to be produced may include concepts proposed by either industry or academic institutions. Investigators wishing to access these services may submit proposals following the guidelines found on the DAIDS Guidelines for Requesting Access to Animal Models, Vaccine Reagents and Vaccine Development Resources web page.
Contact:
Dr. Michael Pensiero
Division of AIDS, Preclinical Research and Development Branch
Phone: 301-435-3749
Email: mpensiero@niaid.nih.gov