Influenza virus-like particles produced in Nicotiana benthamiana protect against a lethal viral challenge in mice

Abstract

Very few vaccine platform technologies can pretend to provide an adequate response to the threat of pandemic influenza. Most, if not all, current manufacturing approaches are too slow to respond, have limited surge capacity, and/or are very expensive to operate. Here, we describe the development and clinical testing of a new VLP pandemic vaccine candidate produced under standard good manufacturing process (GMP) conditions from a plant-based manufacturing system. Our results show that this production system can produce high yields of influenza hemagglutinin antigen at high purity in a very short period of time. Because this platform uses recombinant technology and plants as the “bioreactors” to produce the vaccine antigen, the lag time to production of the first doses is short (only 3–4 weeks after publication of the novel influenza strain HA sequence data), and the surge capacity is excellent. These vaccines have been well tolerated in >800 human subjects dosed to date and trigger strong and cross-reactive immune responses at relatively low doses.