Schistosomiasis (Bilharzia) is the second most lethal parasitic worm disease, infecting approximately 207 million people and causing 280,000 deaths annually worldwide. Thanks to generous donations from Mort and Chris Hyman and Mr. Len Blavatnik, trustee at the Blavatnik Charitable Foundation, the Schistosomiasis Vaccine Program is becoming a reality. The program will utilize and leverage existing programmatic and technical infrastructure from the Human Hookworm Vaccine Initiative (HHVI) with the goal of developing a cost-effective schistosomiasis vaccine.
Currently, the Sabin research team has identified an efficient expression system in its George Washington University labs, and is prepared to conduct process development, pilot manufacture, and preclinical testing of the Sm-TSP-2 schistosomiasis vaccine in preparation for a Phase 1 clinical trial in adults in Brazil.
Steady Progress with Hookworm Vaccine Development
Now in its eighth year, the Human Hookworm Vaccine Initiative’s scientific and data-driven approach has elucidated the need for additional basic research activities for the evaluation of potential vaccine antigens for helminth infections. These worm infections impact 576 million people around the world and are significant contributors to the seemingly endless cycle of poverty that ensnares the majority of those infected. An investigational new drug application (IND) is targeted for submission to the United States Food and Drug Administration (FDA) in July 2008 for clinical testing of a skin test reagent for Na-GST-1, one of several hookworm antigens in the development pipeline.
Background on Sabin’s Vaccine Development:
Currently Sabin has two significant vaccine programs in development with other initiatives being explored. The Human Hookworm Vaccine Initiative is the most established product development program and partnership, which is committed to the development of a hookworm vaccine in the non-profit sector. Over the past eight years, hookworm initiative has built up personnel and infrastructure to become a fully equipped vaccine development program. The hookworm initiative has also established and maintained successful international partnerships with The Oswaldo Cruz Foundation (FIOCRUZ), a part of the Brazilian Ministry of Health and Instituto Butantan, a Sao Paulo state-owned vaccine manufacturer that produces 80% of vaccines in Brazil, where clinical testing sites are located and technology transfer activities have commenced.
The newest vaccine program for Schistosomiasis leverages the hookworm vaccine infrastructure in order to test for an economical vaccine that would combat one of the deadliest NTDs. Using the same best practices and ethical standards, the team of leading researchers and medical professionals are working to save the lives of millions children who die every year as a result of their inability to access the needed medicines to combat this disease.