972215A single dose ambient temperature stable vaccine for the prevention of Zika virusClosedSmall Business Research InitiativeInnovate UKThe last 12 months has seen rapid spread of the Zika virus from Africa and Asia to the Americas with over 30 countries in this region now reporting Zika virus infections. The majority of these south and central American territories have high levels of poverty. While infection with this virus is rarely fatal, the virus has been associated with causing Guillain-Barré syndrome. This disease leads to long term damage of the nervous system. Furthermore, the virus is also associated with causing congenital microcephaly of new-born babies where the mother acquired a Zika virus infection during pregnancy. Consequently, there is a demand for a vaccine suitable to combat Zika virus infection particularly in low-income settings where infection rates are highest. We propose to develop a vaccine from a pre-existing attenuated live measles vector strain that has been administered safely to hundreds of millions of people, mostly children, without relevant safety concerns. Moreover, this system has recently been used for another experimental measles-vectored vaccine that was proven as safe and resulted in an excellent clinical response. This vector is genetically engineered to express Zika virus proteins intracellularly that will allow a single dose to be effective with the vaccine providing persistant durable immunity over the long term. The vaccine will be used in low to middle income settings where there will be limited or intermittent cold chain capabilities. Therefore, the vaccine will be formulated using a novel silk fibroin technology. This technology will be evaluated over 12 months on its ability to confer stability to the vaccine even when exposed to high temperatures (>30 Celsius). Furthermore, the existing high yield production system allows a reduction in the cost of goods for low income settings. Within 18 months of the project start, a Zika vaccine will be fast-tracked for safety and efficacy assessment in a phase I clinical trial based in Europe. The vaccine’s effectiveness to protect will be assessed based upon the ability of the serum from the vaccine recipient to neutralize wild type Zika virus in an animal model. Finally, an in-vivo bridging study will demonstrate equivalency of the existing and the high stability formulation.