This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to
prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of
gastrointestinal diseases in the world. Norovirus infections can cause vomiting, diarrhea,
and cramping. Noroviruses can spread easily, especially in hospitals, schools, military
barracks and ships. At the moment, there is no vaccine available to prevent norovirus
infections or disease. This clinical trial will look at the safety and tolerability of an
investigational vaccine that is being developed to prevent norovirus-related disease. The
trial will also look at whether the immune system produces a response to the investigational
study vaccine. The study vaccine is a combination of two different types of norovirus
antigens. In contrast to similar vaccines under development, the vaccine studied here adds no
substances (adjuvants) to increase or modulate the immune response. The study vaccine is
produced using a plant-based system rather than a typically used animal cell system. This is
the first time the study vaccine will be given to humans. Two different doses of the
investigational study vaccine will be tested in this trial. Either the investigational study
vaccine or the placebo will be given as 2 injections. These injections will be given about 1
month apart. The trial will last about 12 months, from the time of enrollment.