Requests for Vaccine Development Resources
NIAID has placed a high priority on the development of safe and effective HIV vaccines for worldwide evaluation and use. The HIV-1 Vaccine Development Resources (VDR) contracts were designed to aid the preclinical development of promising vaccine candidates from the research laboratory to the clinic. As such, it offers an array of resources to facilitate development of a promising candidate into a testable product. Resources are available to accomplish three basic functions:
| A. |
Manufacturing of GMP pilot lots of vaccine for testing in humans or GLP/reagent-grade vaccine for testing in nonhuman primates |
| B. |
Performing tests for safety and immunogenicity and other preclinical testing of GMP-produced candidates |
| C. |
Preparing U.S. Food and Drug Administration submissions leading up to human trials |
In the area of vaccine manufacturing, resources are currently available to produce trial vaccines within the following categories:
| A. |
Recombinant protein subunits |
| B. |
DNA vaccines |
| C. |
Poxvirus vector-based vaccines |
| D. |
Whole killed virus |
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 Division of AIDS Guidelines for Requesting Access to Animal Models, Vaccine Reagents and Vaccine Development Resources Web page or download the instructions for offline review.
Contact
Michael Pensiero, Ph.D.
Division of AIDS, Preclinical Research and Development Branch
Phone: 301-435-3749
Fax: 301-402-3684
E-mail: mpensiero@niaid.nih.gov
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