This project is designed to prepare a GMP quality investigational HIV vaccine and complete the preclinical and laboratory studies needed to begin a clinical trial. The Vaccine Research Center (VRC), NIAID is developing a novel prime-boost HIV vaccine strategy directed at the three most globally prevalent HIV subtypes (clades). VRC's HIV prime-boost candidate is designed to elicit immune responses to HIV sequences from clades A, B and C which together cause about 90 percent of incident HIV infections around the world. This product has since been evaluated clinically as a single agent and as part of a DNA prime-adenovector boost regimen in over 100 study subjects in several Phase 1 and 2 clinical trials in U.S. and international sites. Production of Phase II materials has been completed.
|Liu, Jonathan; Mani, Sachin; Schwartz, Richard et al. (2010) Cloning and assessment of tumorigenicity and oncogenicity of a Madin-Darby canine kidney (MDCK) cell line for influenza vaccine production. Vaccine 28:1285-93|
|Liu, Jonathan; Shi, Xiao; Schwartz, Richard et al. (2009) Use of MDCK cells for production of live attenuated influenza vaccine. Vaccine 27:6460-3|
|Minor, Philip D; Engelhardt, Othmar G; Wood, John M et al. (2009) Current challenges in implementing cell-derived influenza vaccines: implications for production and regulation, July 2007, NIBSC, Potters Bar, UK. Vaccine 27:2907-13|
|Wang, Lingshu; Cheng, Cheng; Ko, Sung-Youl et al. (2009) Delivery of human immunodeficiency virus vaccine vectors to the intestine induces enhanced mucosal cellular immunity. J Virol 83:7166-75|