VRC01 is the first of several exceptionally broad NAbs and has been chosen to be produced as a clinical product for human. Testing of this NAb in humans can provide information relative to the ability of this NAb to provide protection from HIV acquisition and as to whether a vaccine designed to elicit a similar antibody response might be expected to provide similar protection from acquisition from HIV. The next step in bringing the VRC antibody and vaccines to market involves producing large quantities of the bnmAb for use in clinical trials. Vaccine Production Program at the VRC is responsible for cGMP production, pre-clinical safety testing and regulatory submission of VRC vaccines for clinical trials. To expeditiously meet the critical program needs of its Clinical Trials Core, the VRC developed a Vaccine Pilot Plant (VPP) for the manufacture of clinical materials for Phase I/II/III trials. To date, VRC vaccines have been developed and manufactured by the Vaccine Production Program through collaborations with companies in the vaccine/biotechnology industry, via contracts that enable process and assay development, GMP manufacturing and product release/stability testing. Such an approach enables the VRC to rapidly respond to emerging public health threats.
|Ledgerwood, Julie E; Coates, Emily E; Yamshchikov, Galina et al. (2015) Safety, Pharmacokinetics, and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults. Clin Exp Immunol :|