Influenza vaccines conferring immunity against multiple strains of virus will be manufactured for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity a universal influenza vaccine over a period of several years against multiple strains in contrast to seasonal products that are only useful for a single season. If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale. Such vaccines would be effective over multiple seasons and would require lengthy clinical study and monitoring for effectiveness across strains that vary from season to season.
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| 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 |
