VASA | Vaccine Against Schistosomiasis for Africa. A Phase I clinical study of the SchistoShield® anti-schistosomiasis vaccine in adults in endemic areas of sub-Saharan Africa

Original description

Schistosomiasis is a poverty-related neglected tropical disease, impacting one billion people in 74 countries. Science ranked a schistosomiasis-vaccine as one of the top-10 vaccines urgently needed. Chemotherapy is the preferred method for schistosomiasis control; but the effectiveness of mass-treatment programs is compromised by reinfection requiring regular re-treatment. An efficacious vaccine, with long-lasting protection against all schistosomiasis forms, would impact disease control. We request funding for the clinical development of our SchistoShield®-vaccine (Sm- p80 antigen+GLA-SE adjuvant) in Burkina Faso and Madagascar, where Schistosoma mansoni (causing intestinal/ hepatic schistosomiasis) and S. haematobium (causing urinary schistosomiasis) are endemic. In baboon studies, SchistoShield® has been effective against all major schistosome species. It is the only vaccine candidate having consistently exhibited potent prophylactic, anti-fecundity, egg-induced pathology resolving, transmission-blocking and therapeutic efficacy. The objectives are to 1) assess the safety/immunogenicity of SchistoShield® in a Phase I clinical study in healthy adults from Africa; 2) refine and develop a female worm schistosome human challenge model; 3) identify correlates of protection, innate and adaptive immune signatures, gene expression and the role of antibodies in the prevention/control of Schistosoma infections; and 4) foster a global consortium to advance research on schistosomiasis disease burden, vaccines and address downstream access constraints in resource-poor settings. The funding requested will allow the clinical development of SchistoShield®. African site research capacity will be improved and epidemiological burden data using novel diagnostic techniques will be used to advance clinical development to Phase 2 and potential future elimination project

Status

SIGNED

Url

https://cordis.europa.eu/project/id/815643

Call topic

SC1-BHC-15-2018

Update Date

26-10-2022