Product Development: Vaccines and Immune Therapeutics

Research Project 2: Joseph Barbieri, Eric Johnson and colleagues generated a recombinant heavy chain vaccine that protects mice against botulinum neurotoxin. Key questions are whether the HCR vaccine can protect against all neurotoxin forms and whether the HCR vaccine can protect non-human primates to fulfill the FDA's two animal rule criteria.

Research Project 4: Robert Brubaker, Bana Jabri, Olaf Schneewind and colleagues generated the rV10 subunit vaccine that protects mice against a lethal pneumonic plague challenge with >100,000 MLD of Yersinia pestis CO92. Key questions include whether the rV10 vaccine can protect non-human primates in an aerosol challenge to fulfill the FDA's two animal rule criteria.

Research Project 4: John Xu and colleagues demonstrated that IL-10 knockout mice are resistant to plague infections at least at lower LD50 ranges. Together with the observation that humoral immune response against LcrV can mitigate the IL-10 mediated immune suppressive effects of LcrV (R. Brubaker), these data suggest that antibodies against IL-10 could serve as a biodefense product for the therapy of plague. Key question is whether the current data support this product development.

Research Project 5: Yoshihiro Kawaoka and colleagues have constructed an attenuated Ebola virus as a vaccine strain that generated sterile immunity in mice and monkeys challenged with Ebola virus. The key question is whether this attenuated Ebola virus can be further attenuated to address safety concerns.

Developmental Project 3: James Baker Jr. and colleagues demonstrated that nanoemulsions consisting of soybean oil, emulsifying agents and ethanol successfully and rapidly kills vaccinia virus. Further, nanoemulsion treated vaccinia virus induces an immune response in mice when delivered intra-nasally. This technology is already slated for product development. Link: University of Michigan Nanotechnology Institute for Medicine and Biological Sciences

Developmental Project 8: Laura Knoll reported the successful generation of cyst development mutants of Toxoplasma gondii that cannot persist in mice. Such mutants represent potential vaccine vehicles for vaccination against T. gondii as well as Cryptosporidium spp.

Developmental Project 11: Anna Bielinska, James Baker Jr. and colleagues report a mucosal nanoemulsion-rPA vaccine that protects mice against anthrax. The key question is whether this vaccine formulation can be protective in other animal models of anthrax disease. Link: University of Michigan Nanotechnology Institute for Medicine and Biological Sciences

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