Safety and immunogenicity of the Sm-p80 GLA-SE schistosomiasis vaccine.

Schistosomiasis is a neglected tropical disease with the greatest burden in sub-Saharan Africa. An efficacious and safe vaccine would have a major global public health impact. The investigational SchistoShield® (Sm-p80 [antigen] + GLA-SE [adjuvant]) vaccine targets the Sm-p80 surface membrane antigen of Schistosoma mansoni and in nonhuman primate challenge studies was shown to be highly effective in killing pathogenic female worms and reducing host organ pathology and egg excretion. In this Phase 1 first-in-human, dose-escalation trial with sequential assignment, we evaluated the safety and immunogenicity of the vaccine in healthy adults in the United States. The vaccine formulations, given as a three dose intramuscular series, were well tolerated and adjuvanted formulations induced robust IgG ELISA responses against the Sm-p80 antigen. The vaccine has been advanced to a Phase 1b trial among adults in endemic areas of Africa.Clinicaltrials.gov registration: NCT05292391 https://Clinicaltrials.gov/study/NCT05292391 .