AAHI’s adjuvant formulations are supporting development of three different schistosomiasis vaccine candidates, currently in early phase clinical testing in Uganda, Brazil, Madagascar, Burkina Faso, and the Netherlands.
AAHI collaborates to provide protection against schistosomiasis.
AAHI is collaborating with partners around the world to develop schistosomiasis vaccines that will deter the worms from considering humans a viable host, and thus may avoid the need for potentially harmful preventive chemotherapy. Three such schistosomiasis vaccine candidates are being clinically evaluated with AAHI’s GLA adjuvant formulations that enhance the body’s immune response to the vaccine.
Baylor College of Medicine is conducting a Phase 1 /2 clinical trial in Uganda evaluating their SmTSP-2 protein on alum combined with AAHI’s GLA-AF adjuvant formulation to protect against intestinal schistosomiasis. The vaccine candidate was proven safe and well- tolerated in a Phase 1 clinical trial conducted in Minas Gerais, Brazil (NCT02337855 & NCT03910972).
Another vaccine candidate, developed by researchers in Brazil, combines a fatty acid binding protein, Sm14, with AAHI’s GLA-SE adjuvant formulation. The Phase 1 clinical trial, sponsored by Oswaldo Cruz Foundation (FioCruz) and conducted in Rio do Janeiro, demonstrated that the vaccine candidate was well- tolerated and induced a favorable immune response (NCT01154049). The researchers recently completed Phase 2 clinical trials in Senegal to protect school children between the ages of 8 and 11 (NCT03799510) and are currently recruiting for a clinical trial in Senegalese adults exploring different vaccine dosing regimens (NCT05658614).
A third vaccine candidate called SchistoShield®, combining a recombinant protein Sm-p80, or calpain, with AAHI’s GLA-SE adjuvant formulation, entered clinical testing in 2022 in Seattle, supported by the National Institute of Allergy and Infectious Diseases (NIAID) (NCT05292391). Researchers have plans to commence a Phase 1b clinical trial in Madagascar and Burkina Faso, with a human challenge model study planned in the Netherlands.
Schistosomiasis is caused by infection with parasitic trematode worms. Certain species of fresh-water snails, native to Africa and Brazil, carry the worms, which are shed in larval form. Once released by the snails, the larval worms, or bloodflukes, actively seek hosts. They use their forked tails to penetrate the skin of people who are bathing, swimming, or washing clothes, entering their bloodstreams, and nesting in various organs, particularly the intestines, bladder, and genitals. In 2019, almost two and half million people were treated with mass chemotherapy to kill such infestations. Since 2020, 66% of countries where schistosomiasis is endemic require preventative chemotherapy to combat schistosomiasis.