Phase 1 Clinical Trial of Sm-TSP-2 Schistosomiasis Vaccine Begins
WASHINGTON, D.C. — June 3, 2015 — The Sabin Vaccine Institute Product Development Partnership (Sabin PDP) today released an update on a Phase 1 clinical trial of its vaccine candidate to prevent intestinal schistosomiasis, Sm-TSP-2/Alhydrogel®. Schistosomiasis is one of the most pervasive neglected tropical diseases (NTDs) affecting the world’s poorest communities. The Sabin PDP is based at the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine (BCM) in Houston, Texas.
The trial, which began in January 2015, is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. It will test the safety, reactogenicity and immunogenicity of the vaccine in healthy, non-infected adults in the United States. The Sm-TSP-2/Alhydrogel® vaccine is being tested in combination with the GLA-AF adjuvant developed by the Infectious Disease Research Institute (Seattle, WA). A total of 72 volunteers will be vaccinated during this trial, which is being conducted by the NIAID-supported Vaccine and Treatment Evaluation Unit in at Baylor College of Medicine (BCM) Houston, Texas.
“Developing a vaccine to prevent schistosomiasis — the deadliest of the seven most common NTDs — will provide a long-term solution to combating a disease that traps the poorest communities in a cycle of poverty,” said Peter Hotez, MD, PhD, president of Sabin, director of the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine. “In particular, this trial helps advance our goal to develop a safe, efficacious and low-cost vaccine to reduce the global burden of schistosomiasis, which infects nearly 240 million people worldwide.”
Sabin PDP collaborators also include The George Washington University (Washington, DC); James Cook University (Cairns, Australia); the Macromolecule and Vaccine Stabilization Center at the University of Kansas (Lawrence, KS); and Aeras (Rockville, MD) who have played key roles in the research, development and manufacture of the Sm-TSP-2/Alhydrogel® vaccine candidate.
“This trial marks an important milestone toward preventing intestinal schistosomiasis, using the Sm-TSP-2/Alhydrogel® vaccine to prevent S. mansoni infection,” said David Diemert, MD, director of clinical trials of the Sabin PDP and associate professor at The George Washington University. “We hope this trial will provide a breakthrough to one day turn the tide against schistosomiasis and improve the lives of all those affected by this debilitating disease.”
More information on the study is available here.
About The Sabin Vaccine Institute and the Sabin Vaccine Institute Product Development Partnership
The Sabin Vaccine Institute (Sabin) is a non-profit, 501(c)(3) organization dedicated to reducing needless human suffering from vaccine-preventable and neglected tropical diseases (NTDs) worldwide. Sabin develops new vaccines, advocates for increased use of existing vaccines and promotes expanded access to affordable medical treatments in collaboration with governments, academic institutions, scientists, medical professionals and non-profit organizations. For more information please visit www.sabin.org.
Sabin’s research and development of new vaccines is conducted through a collaboration called the Sabin Vaccine Institute Product Development Partnership (Sabin PDP), which works with leading private, academic and public institutions around the world to develop and test safe, effective and low-cost vaccines for infectious and neglected tropical diseases. A complete overview of ongoing projects and partners is available at www.sabin.org/pdp