The biotechnology-value chain: Development of Sm14 as a schistosomiasis vaccine

In the 1990s, WHO/TDR created a product development program and initiated collaborations with other major international donors to promote rapid vaccine development and other tools for the control of endemic diseases. This “push strategy” was chosen to achieve effective research projects fostering innovation in the context of rapid product development. In the field of vaccine development, the aim was to bring forth ways and means to immunize against the most important human parasite diseases. Although the malaria vaccine projects scored initial successes it has been difficult to move forward decidedly. With regard to schistosomiasis, more than 10 important antigens with strong potential as vaccines candidates emerged from the several 100 scientific projects supported by international donor agencies and national research programs over the last few decades. Among those still seriously pursued, the Fatty Acid-Binding Protein (FABP)-14 kDa Schistosoma mansoni (Sm14) antigen stands out, both due to its steady progress towards field trials and because it represents the sole vaccine candidate to emerge from an endemic country. Work has now progressed to the scale-up level and an industrial production process has successfully been put in place.The very special feature of Sm14 is its strong immunological reactivity with an antigen shared between two different important parasites, which give this vaccine candidate the potential to be used against more than one infection. It has been demonstrated that it has effect not only against S. mansoni in humans but also against Fasciola hepatica, a parasite that causes disease in cattle and sheep leading to annual losses over 3 $US billion to the food industry worldwide. The Sm14 patents, granted to Oswaldo Cruz Foundation (FIOCRUZ), a Brazilian scientific institution directly linked to the Brazilian Ministry of Health, have been licensed to a private company which has the intention to lead the Sm14 project to success, both in the veterinary and in the human field. The objective is to provide economic performance by fostering scientific and economic progress and thus reach the global market. Sm14 is at present at the stage of planning clinical trials under a private–public partnership (PPP) initiative in collaboration with FIOCRUZ which has recently received significant financial support from FINEP, a public Brazilian Financial Agency.