The hepatitis B virus continues to be a major pathogen worldwide despite
the availability of an effective parenteral vaccine for over 20 years.
Orally-delivered subunit vaccines produced in maize may help to alleviate the
disease burden by providing a low-cost, heat stable alternative to the
parenteral vaccine. Oral subunit vaccination has been an elusive goal due to the
large amounts of antigen required to induce an immunologic response when
administered through the digestive tract. Here we show that high levels of HBsAg
were obtained in maize grain, the grain was formed into edible wafers, and
wafers were fed to mice at a concentration of approximately 300µg/g.
When these wafers were made with supercritical fluid extraction (SFE)-treated
maize material, robust IgG and IgA responses in sera were observed that were
comparable to the injected commercial vaccine Recombivax®).
In addition, all mice administered SFE wafers showed high secretory IgA titers
in fecal material whereas Recombivax® treated mice showed no
detectable titer. Increased salivary IgA titers were also detected in SFE-fed
mice but not in Recombivax® treated mice. Wafers made from
hexane-treated, or full fat, maize material induced immunologic responses, but
fecal titers were attenuated relative to those produced by SFE-treated wafers.
These responses demonstrate the feasibility of using a two-dose oral vaccine
booster in the absence of an adjuvant to induce immunologic responses in both
sera and at mucosal surfaces, and highlight the potential limitations of using
an exclusively parenteral dosing regime.