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.
|Suschak, John J; Wang, Shixia; Fitzgerald, Katherine A et al. (2015) Identification of Aim2 as a sensor for DNA vaccines. J Immunol 194:630-6|
|Pouliot, Kimberly; Buglione-Corbett, Rachel; Marty-Roix, Robyn et al. (2014) Contribution of TLR4 and MyD88 for adjuvant monophosphoryl lipid A (MPLA) activity in a DNA prime-protein boost HIV-1 vaccine. Vaccine 32:5049-56|
|Chen, Yuxin; Vaine, Michael; Wallace, Aaron et al. (2013) A novel rabbit monoclonal antibody platform to dissect the diverse repertoire of antibody epitopes for HIV-1 Env immunogen design. J Virol 87:10232-43|
|Buglione-Corbett, Rachel; Pouliot, Kimberly; Marty-Roix, Robyn et al. (2013) Serum cytokine profiles associated with specific adjuvants used in a DNA prime-protein boost vaccination strategy. PLoS One 8:e74820|
|Pan, Ruimin; Sampson, Jared M; Chen, Yuxin et al. (2013) Rabbit anti-HIV-1 monoclonal antibodies raised by immunization can mimic the antigen-binding modes of antibodies derived from HIV-1-infected humans. J Virol 87:10221-31|
|Marty-Roix, Robyn; Lien, Egil (2013) (De-) oiling inflammasomes. Immunity 38:1088-90|
|Wang, Zheng; Zhang, Mingshun; Wang, Yan et al. (2011) A versatile vector for the production of pseudotyped viruses expressing gp120 antigens from different clades of primary HIV-1 isolates. J Virol Methods 171:183-9|
|Vaine, Michael; Duenas-Decamp, Maria; Peters, Paul et al. (2011) Two closely related Env antigens from the same patient elicited different spectra of neutralizing antibodies against heterologous HIV-1 isolates. J Virol 85:4927-36|
|Zolla-Pazner, Susan; Kong, X-P; Jiang, Xunqing et al. (2011) Cross-clade HIV-1 neutralizing antibodies induced with V3-scaffold protein immunogens following priming with gp120 DNA. J Virol 85:9887-98|
|Vaine, Michael; Wang, Shixia; Hackett, Anthony et al. (2010) Antibody responses elicited through homologous or heterologous prime-boost DNA and protein vaccinations differ in functional activity and avidity. Vaccine 28:2999-3007|
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