The overall objective of Project 3 is to coordinate the effort in manufacturing, quality control, and quality assurance of the vaccine components and final vaccine formulation under GMP, organize and oversee the conduct of GLP-level definitive toxicology, biodistribution and integration studies, and finally, deliver a stability tested and FDA reviewed candidate vaccine product for a Phase 1 safety and immunogenicity study to be conducted at NIH's HIV Vaccine Trial Network (HVTN).
Aim 1. To manufacture DNA vaccine components and produce final formulation under cGMP conditions. To conduct appropriate release testing according to DNA vaccine specifications for bulk and vialed DNA vaccine materials.
Aim 2. To manufacture protein vaccine components and produce final formulations under cGMP conditions. To conduct appropriate release testing according to protein vaccine specifications for bulk and vialed materials. To purchase and formulate a GMP-grade adjuvant as part of the protein boost formulation.
Aim 3. To conduct definitive toxicology studies to evaluate the safety of the next generation DNA prime - protein boost HIV-1 vaccine formulation including a new adjuvant. In addition, the biodistribution/integration of a single-dose administered DNA vaccines will be evaluated under cGLP conditions.
Aim 4. To establish Project Management-based operation and control procedures for the coordination of al Project 3 activities including interactions among the different elements of this IPCAVD program and interactions between our program and subcontractors related to the vaccine manufacturing and toxicology studies.
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