WASHINGTON, DC-- Jan. 19, 2012--The Sabin Vaccine Institute (Sabin) today announced the start of a Phase 1 clinical trial of its Na-GST-1 antigen, a candidate for the first human hookworm vaccine. The trial is a major milestone for the vaccine product development partnership (PDP) headquartered at Sabin.
This trial advances Sabin’s goal to develop a safe, efficacious and low-cost vaccine to reduce the global burden of human hookworm, which infects nearly 600 million people worldwide. In close collaboration with our partners, we are conducting the trial in Brazil, where the burden of human hookworm infection is high in endemic areas.
“This vaccine trial is monumental, not just for us, but also for the children living in poverty who bear the burden of hookworm infection,” says Peter Hotez, M.D., Ph.D., president of the Sabin Vaccine Institute and director of the 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.”
The trial will enroll 102 adults between the ages of 18 and 45. Each volunteer will receive three injections over four months. The researchers will then follow each volunteer for 12 additional months, monitoring the vaccine’s safety and analyzing the recipients’ immune responses. Once the safety of Na-GST-1 is confirmed in adults, a trial will be conducted in children, the age group that will ultimately be targeted to receive the vaccine.
“This trial has the potential to revolutionize the control of hookworm-related disease,” says David Diemert, M.D., FRCP(C), of George Washington University, the trial’s principal investigator. “Typically, hookworm infection is treated by annual mass drug administration in pill form to school-aged children in endemic countries. The pills can cure current infections in children, but in heavily endemic areas, rapid re-infection throughout the child’s life and into adulthood can occur. Rather than treating children over and over again, a vaccine, in combination with drug treatment, would help to effectively control and prevent hookworm infection.”
The trial is being conducted by a team based at the Oswaldo Cruz Foundation (FIOCRUZ) of the Brazilian Ministry of Health, a member of the Sabin PDP.
“The involvement of developing world institutions like FIOCRUZ in the development and testing of a hookworm vaccine reflects Sabin’s commitment to ensuring that a successful vaccine will be made available in the world’s impoverished regions,” says Rodrigo Corrêa-Oliveira, Director of the Centro de Pesquisas René Rachou, a Regional Unit of FIOCRUZ.
Hookworm is a soil-transmitted helminth infection caused by the intestinal parasites Necator americanus and Ancylostoma duodenale. Although people living in most middle and upper income countries are largely free from the suffering caused by hookworm, the infection remains widespread in tropical and sub-tropical climates of Africa, Asia and Latin America. Left untreated, hookworm infection causes severe intestinal blood loss leading to iron-deficiency anemia and protein malnutrition, which in turn can result in impaired physical and cognitive development in children.
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.
About Sabin’s PDP
The Sabin PDP is the world's first and only vaccine initiative targeting human hookworm infection and other neglected tropical diseases. This product development partnership (PDP) engages partners in academia, industry, government and civil society to fill an important market gap by collaborating with world class research and development institutions to create ultra low-cost vaccines for poor and underserved populations. Other PDP members include Texas Children’s Hospital and Baylor College of Medicine, the George Washington University, the Oswaldo Cruz Foundation (FIOCRUZ), the London School of Hygiene and Tropical Medicine (UK), the Queensland Institute of Medical Research (Australia), Instituto Butantan (Brazil) and the Institute of Parasite Diseases of the Chinese Centers for Disease Control and Prevention.