HIV VACCINE PRODUCTION

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Abstract

The objective of this contract is to produce, scale-up, characterize and formulate reagent grade (GLP) and /or clinical grade (cGMP) HIV-1DNA plasmid vaccine products for animal and/or human trials. For clinical grade materials the manufacturer must perform all required vaccine lot characterization tests. The contractor must also work together with other contractors performing safety and immunogenicity testing of the vaccine product or producing FDA-required documentation in support of an IND.