The goal of Project 3 is for Crucell to vial, release, and manage clinical-grade Ad26 vectors expressing HlV-1 mosaic Env/Gag/Pol antigens and our stable clade C HlV-1 Env gp140 trimer for the phase 1 studies described in Project 2 as well as for potential future phase 2a/2b clinical studies. As part of our ongoing IPCAVD A1078526 program, we are currently manufacturing multivalent Ad26 vectors expressing mosaic Env/Gag/Pol antigens as well as our stable clade C gp140 trimer under GMP conditions for clinical trials. Sufficient bulk material will be manufactured to support both phase 1 and phase 2a/2b clinical trials. However, our IPCAVD AI078526 program will end in 2013, and thus we would require this new IPCAVD grant to develop these novel HlV-1 vaccine candidates further. In this project, Crucell will fill and release the remainder of the Ad26 drug substance and the HIV-1 Env gp140 trimer to support the phase 1 studies described in Project 2 and for potential future phase 2a/2b clinical studies. Crucell will also provide all the regulatory and project management support required for this IPCAVD program. To accomplish these goals, we propose the following three Specific Aims: 1. To vial, release, and monitor stability of clinical-grade Ad26 vectors expressing HlV-1 mosaic Env/Gag/Pol antigens under GMP conditions; 2. To vial, release, and monitor stability of clinical-grade HlV-1 Env gp140 trimer under GMP conditions;and 3. To provide the regulatory and project management support required for this IPCAVD program.
Manufacturing and regulatory support of GMP-grade vaccine products are critical for the development of an HlV-1 vaccine. In this Project, Crucell will provide the product, regulatory, and project management support required forthis IPCAVD program.
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