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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI096040-02
Application #
8487360
Study Section
Special Emphasis Panel (ZAI1-EC-A)
Project Start
Project End
Budget Start
2013-06-01
Budget End
2014-05-31
Support Year
2
Fiscal Year
2013
Total Cost
$1,591,960
Indirect Cost
$411,482
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
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