SBIR Phase II: Optimization of Rotavirus Vaccine Production

To improve the safety and efficacy of oral rotavirus vaccines, CDC scientists have developed a proprietary inactivated rotavirus vaccine (IRV) technology (new human strains and a novel method for rotavirus inactivation) and demonstrated the immunogenicity in mice [14] and protective efficacy in piglets [15] of this IRV by intramuscular (IM) administration. More recently, CDC scientists have demonstrated enhanced immunogenicity of IRV using an innovative microneedle patch technology, achieving comparable antibody titers with a 1/10th of the antigen dose compared to those induced by a full IM dose of vaccine. Microneedles provide a simple and painless method to administer vaccines without using hypodermic needles. They are inexpensive to manufacture and may not require a cold chain for storage and transport, a major advantage for immunization campaigns in the developing world. With the establishment of proof of concept for IM and skin immunization in animals, CDC has entered an agreement with Meridian Life Science (MLS) to produce a master virus bank (MVB) under Good Manufacturing Practice (GMP) conditions at the MLS facilities in Memphis, Tennessee. Based on the results and progress from the Phase I SBIR contract, the phase II contract will focus on preparation of inactivated rotavirus vaccine pilot lots for phase I clinical trials.