3.2 Stability, functionality, and immune response is preserved
after storage for 6 months
Plant seeds has natural ability to protect the vaccine antigen by
bioencapsulation in the plant tissues, and therefore allow its storage
at ambient temperature, moisture, and light conditions, and thus
simplifies its production and distribution. We have tested our plant
made vaccine antigen for confirmation of immunogenicity after long-term
storage. The immunoblot (Fig. 3) confirmed TM-1 vaccine antigen can be
stored at ambient temperature without degradation for at least six
months. The confirmation of immune response is evident of such
bioencapsulation where vaccine antigen was intact during passing through
digestive system. Cell wall mediated bioencapsulation allow proteins to
withstand enzymatic condition and can reach the small intestine, where
the TM-1 vaccine antigen was incorporated into M cells in the
follicle-associated epithelium (FAE), and finally to systemic immune
responses. The CTB is FDA approved as fusion protein for delivery of
biopharmaceuticals into immune system. The furin sites are incorporated
between CTB and TM1 antigen for its delivery upon its cleavage. In
addition, such results are encouraging because this protection to
withstand biodegradation elements and stability at normal room
conditions would allow plant made vaccine to eliminate the moderate to
ultra-cold conditions required for vaccine storage and distribution.
Also, we confirmed the feasibility of oral delivery of plant made
vaccine production and its efficacy for animals with efficient delivery
vehicle such as CTB and cleavage sites