The initiative includes two companies belonging to the Tuscany Life Science Cluster and will allow development up to the clinical stage of a vaccine for Africa using a technology developed in Siena.
The Government of the Tuscany Region together with the Achille Sclavo Foundation and the University of Siena, signed a grant agreement to support the project: “Development of a vaccine against invasive Non-Typhoidal Salmonellosis in Africa”, (S-AFRIVAC), focusing on the preclinical development of a vaccine against this endemic neglected disease in Africa. S-AFRIVAC ranked 4th out of 70 projects selected by the Region of Tuscany under the call FAS-Health 2014, action: “Support to the advancement or research projects in the areas of quality of life, human health, biomedicine, innovative drugs development”. The two-year grant is worth more than €1 million for the work performed by Fondazione Sclavo and the University of Siena, in addition to the synergistic investments made by two private project partners: GSK Vaccine Institute for Global Health and VisMederi. All these investments will allow complete pre-clinical development of the vaccine offering the possibility to begin clinical trials in 2018.
The Achille Sclavo Foundation, pursuing its Mission to “Reduce infant mortality and improve health and living conditions in low-income countries, by accelerating availability of new affordable life-saving vaccines to eliminate neglected infectious diseases and training local health workers, thereby reducing poverty”, will act as scientific and technical coordinator of the S-AFRIVAC project and will be responsible for attracting needed co-funding. The Achille Sclavo Foundation will also be responsible for: assisting in the production of clinical material for the phase I study, preparing an epidemiological model of the disease aimed at correctly estimating its burden, and proposing a sustainable immunization strategy using a new effective, sustainable vaccine for a disease plaguing the African Continent.
Invasive Non-Typhoidal salmonellosis (iNTS) in Africa is one of the great neglected diseases of poverty: we now have enough data from careful hospital and population-based studies to know that iNTS is a major cause of disease and death in Africa. In several studies, iNTS was the leading bloodstream infection ranking alongside pneumococcus. This is true across sub-Saharan Africa: from Gambia and Senegal in the West, Kenya and Uganda in Eastern Africa, The Congo in Central Africa and Malawi and Zimbabwe in Southern Africa. A vaccine is badly needed for iNTS: the incidence of gastroenteritis caused by iNTS was estimated in 2010 at 93 million cases, resulting in 155,000 deaths. These deaths mainly occur in children, but also in people affected by HIV, malaria, anemia or undernourishment. The disease kills very rapidly (about a 20% case fatality rate in children that make it to the hospital: around 1/2 within 24 to 48 hours), and because the disease is difficult to diagnose, and is frequently misdiagnosed, appropriate treatment often does not start in time. Furthermore, the strains of Salmonella that cause iNTS are highly drug resistant and need expensive new-generation antibiotics.
Dr. Rino Rappuoli, world leader in the vaccine field, Deputy President of the Achille Sclavo Foundation, and Scientific Coordinator of the project, stated: “In the last years, incredible progress has been made in providing an increasing number of effective vaccines against pediatric infectious diseases for low-income countries. Many other infectious diseases, deadly for millions of infants, children and adults still remain without an effective vaccine. And this is not because they are not technologically feasible, but because little to no money has been invested in eradicating these epidemic diseases in developing countries. The goal of S-AFRIVAC, with the support of the Tuscany Region, is to accelerate the transition of this new vaccine to the target population in Africa, bridging this gap”.
The project has very solid scientific basis: a Shigella vaccine using the same technology has already gone through phase I, and the production process of the vaccine points towards a very good cost/benefit ratio. The targeted use of this innovative and reliable technology, together with a deep understanding of the infectious diseases and their preventative measures on the part of the people and companies involved in it, make this project very promising for a rapid development of a new, safe, effective and low-cost vaccine, particularly relevant for low and middle income countries. This new partnership is very diverse: the project includes public organizations and research institutions, industries and private no-profit entities: a very good example of a Collective Impact project, where all partners from different sectors bring their contribution towards a common shared social goal.
The Fondazione Achille Sclavo is a philanthropic, non-profit organization carrying out scientific research in support of the underprivileged.