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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 put in place 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:

  • Manufacture GMP pilot lots of vaccine for testing in humans, or GLP/reagent grade vaccine for testing in nonhuman primates
  • Perform tests for safety, immunogenicity and other preclinical testing of GMP produced candidates
  • Preparation of Food and Drug Administration (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.

Notable accomplishments to date from this contract are:

  • Manufactured DNA, Pox vector, Influenza, and Listeria vaccine candidates 
  • Prepared/assembled 4 INDs 
  • Prepared the CMC (Chemistry, Manufacturing, and Control) Section of pox-vectored IND 
  • Conducted 13 cGMP compliance audits 
  • Conducted 2 GLP compliance audits 
  • Implemented and managed multiple databases (NHP, regulatory, clinical) 
  • Established a stability program and relevant potency assay for Pox-vectored vaccines 
  • Initiated subcontracts for cGMP manufacture and preclinical testing of a replication competent adenoviral vector 
  • Conducted non-HIV projects for other viral and bacterial diseases (Division of Microbiology and Infectious Diseases)

Contact

Michael Pensiero, Ph.D. 
Division of AIDS, Preclinical Research and Development Branch
Phone: 301-435-3749
Email: mpensiero@niaid.nih.gov

Last Updated December 01, 2009