This SBIR Phase I project will test the feasibility of incorporating a novel vaccine technology to diphtheria, tetanus, and acellular pertussis (DTaP) vaccine to produce a thermostable and orally administered formulation. Vaccines are one of the best investments in global public health and are estimated to save 2-3 million lives per year and protect more than 100 million lives from illness and disability. This project proposes to use a novel vaccine technology platform that targets immune cells in the intestine, enducing a broad immune response, and retains stability at room temperature. This technology has the potential to minimize dependence on the cold-chain and trained medical professionals to administer the vaccine, which are barriers to full vaccine coverage. Additionally, it has potential to increase uptake of vaccine booster doses for adults, with convenience of self-administration and reduced anxiety with no needles. Finally, successful formulation of an oral DTaP vaccine would open the doors to other antigens to be delivered orally. This technology can significantly improve national health, which is one of the missions of NSF. Additionally, switching vaccines to thermostable, oral delivery form is very cost-effective and will alleviate the burden and cost of cold-chain and professional to administer the vaccines. This SBIR Phase I project will test the application of a novel delivery technology to the DTaP vaccine. The highly innovative delivery platform consists of a novel adjuvant, a C-type lectin (CTL) receptor ligand with aluminum hydroxide that targets mucosal immune cells for a strong synergistic boosting of broad immune response, and microencapsulation of the vaccine to resist the strong acidic environment of the stomach. This technology can be incorporated into existing or new vaccines enhancing stability and allowing oral delivery. The first goal of this project includes incorporation of CTL receptor ligand to the DTaP vaccine and applying enteric microencapsulation to the particles to protect the vaccine from low pH. Extensive testing and experiments will be conducted to obtain the optimal formulation of the final oral vaccine. The second goal will be to test and compare the potency of the newly formulated vaccine with a commercially available DTaP vaccine in mice. The final goal will be to test and compare the stability of both vaccines at high temperatures. Successful completion of all objectives will provide a great base for commercial feasibility of the technology. This technology has the potential to be incorporated on any vaccine that can benefit from a thermostable and orally delivery platform.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
