IDRI Supports the First Phase 1 Human Hookworm Vaccine Clinical Trial
Seattle, WA | January 31, 2012
The Infectious Disease Research Institute (IDRI) announced its technical support of the Sabin Vaccine Institute's (Sabin) first ever Phase 1 clinical trial of a human hookworm vaccine candidate, which began last week in Brazil. The trial is a very significant and critical step toward developing a vaccine that would reduce the global burden of human hookworm by providing effective long-term protection for those who are most at risk.
Hookworm is a soil-transmitted infection caused by intestinal parasites effecting approximately 600 million people worldwide. As a disease endemic to regions exasperated by poor economic circumstance, hookworm thrives in the tropical and subtropical climates of Africa, Asia, and Latin America. When left untreated, the infection causes severe intestinal blood loss leading to anemia and malnutrition, which in turn can result in impaired physical and cognitive development particularly in children.
IDRI has contributed its proprietary GLA-AF adjuvant for use as a component of the hookworm vaccine, the basis of which is Sabin's Na-GST-1 antigen. Adjuvants are molecular compounds that help to stimulate a person's immune system in order to make a vaccine more effective. They can also reduce the amount of vaccine needed which helps keep the cost to patients as low as possible. GLA formulations have been previously tested clinically with promising results.
The clinical trial is being conducted by the Oswaldo Cruz Foundation (FIOCRUZ) of the Brazilian Ministry of Health and will enroll 102 adults between the ages of 18 and 45. Each volunteer participant will receive three injections of Sabin's candidate vaccine over a period of four months. Researchers will then follow each volunteer for 12 additional months, monitoring the vaccine's safety and analyzing the recipient's immune response.
"This vaccine trial is monumental, not just for us, but also for the children living in poverty who bear the burden of hookworm infection," said Peter Hotez, M.D., Ph.D., President of the Sabin Vaccine Institute, 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. "After more than 10 years of research and development work and with the help of Sabin's PDP partners, especially our partners in Brazil, we are about to show that it's possible to produce a vaccine candidate using a relatively low-cost model. We are filling a gap to produce a vaccine for underrepresented populations, where no traditional commercial market currently exists."
"We are thrilled to be working with the Sabin Vaccine Institute to support their efforts in addressing human hookworm infection, and are confident that IDRI's adjuvant technology can help build an effective vaccine," said Steven G. Reed Ph.D., IDRI Founder, President, and Chief Scientific Officer. "This important new candidate vaccine is the first of its kind, and could be the solution in fighting this terrible disease."
About Sabin Vaccine Institute
Sabin Vaccine Institute is a non-profit, 501(c)(3) organization of scientists, researchers, and advocates dedicated to reducing needless human suffering caused by vaccine preventable and neglected tropical diseases. Sabin works with governments, leading public and private organizations, and academic institutions to provide solutions for some of the world's most pervasive health challenges. Since its founding in 1993 in honor of the oral polio vaccine developer, Dr. Albert B. Sabin, the Institute has been at the forefront of efforts to control, treat, and eliminate these diseases by developing new vaccines, advocating use of existing vaccines, and promoting increased access to affordable medical treatments. For more information please visit www.sabin.org.
The Infectious Disease Research Institute (IDRI) is a Seattle-based not-for-profit organization committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty. By integrating capabilities, including early stage drug discovery, preclinical testing, manufacturing, and clinical trials, IDRI strives to create an efficient pathway bringing scientific innovation from the laboratory to the people who need it most. For more information, visit www.idri.org.