WASHINGTON, D.C.—June 13, 2012—Today, the Sabin Vaccine Institute, in partnership with the George Washington University and the Children's National Medical Center, began vaccinating participants for a Phase 1 clinical trial of a novel human hookworm vaccine. The trial will investigate the Na-GST-1 antigen developed by the Sabin Vaccine Institute Product Development Partnership (Sabin PDP) to prevent hookworm infections in endemic areas.
"This trial signifies the great progress global health leaders are making to help combat diseases of poverty," said Dr. Peter Hotez, president of the Sabin Vaccine Institute and director of the Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development. "This trial helps advance our 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." Dr. Hotez is also the founding dean of the National School of Tropical Medicine at Baylor College of Medicine.
This study will help to quickly determine the optimal vaccine formulation for future clinical testing of the Na-GST-1 antigen. A critical component of the vaccine being tested is a novel adjuvant developed by the Infectious Disease Research Institute (IDRI) of Seattle, Washington. The adjuvant, GLA-AF, could potentially help to stimulate the immune system for an improved specific antibody response to the vaccine antigen.
"We hope that this trial will offer us the breakthrough we need to ultimately stop transmission of this parasite, especially among the world's poorest," said Dr. Jeff Bethony, Associate Professor of Microbiology, Immunology and Tropical Medicine at the George Washington University.
The clinical trial is based at the Children's National Medical Center in Washington, D.C. The trial will enroll 72 healthy adults between the ages of 18 and 45 residing within the Washington, DC metropolitan area. 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.
A concurrent trial of the Na-GST-1 antigen began in November 2011 in Brazil, an area with a high hookworm disease burden in endemic regions. The Brazil 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.
"By conducting clinical trials in both Brazil and here in the United States, we will be able to rapidly determine the best formulation of the Na-GST-1 vaccine to advance into future vaccine trials in children, the population most at risk of hookworm disease. At the same time, we will help improve biotechnology capacity in an endemic country," said Dr. David Diemert, Principal Investigator of both clinical trials and an Associate Research Professor at the George Washington University.
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.
Established in 2000 with funding from the Bill & Melinda Gates Foundation and with additional support from the Dutch Ministry of Foreign Affairs, the Brazilian Ministry of Health, the George Washington University, and the Children's National Clinical and Translational Science Insititute, the Sabin PDP is the first and only program that aims to reduce the prevalence of human hookworm infection by developing the world's first vaccine targeting the disease.
To learn more about the clinical trial being conducted at the Children's National Medical Center, please visit www.sabin.org.
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 focused on developing vaccines targeting neglected tropical diseases and the world's first and only vaccine initiative targeting human hookworm infection. 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, Baylor College of Medicine, the George Washington University, the Oswaldo Cruz Foundation (FIOCRUZ), the London School of Hygiene and Tropical Medicine (UK), the James Cook University (Australia), Instituto Butantan (Brazil) and the Institute of Parasite Diseases of the Chinese Centers for Disease Control and Prevention (China).
About the School of Medicine and Health Sciences
Founded in 1825, the GW School of Medicine and Health Sciences (SMHS) was the first medical school in the nation's capital and is the 11th oldest in the country. Working together in our nation's capital, with integrity and resolve, the GW SMHS is committed to improving the health and well-being of our local, national and global communities. www.smhs.gwumc.edu
About Children's National Medical Center
Children's National Medical Center in Washington, DC, has been serving the nation's children since 1870. Home to Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is consistently ranked among the top pediatric hospitals by U.S.News & World Report and the Leapfrog Group. Children's National is a Magnet® designated hospital. With 303 beds and eight regional outpatient centers, Children's National is the only exclusive provider of acute pediatric services in the Washington metropolitan area. For more information, visit ChildrensNational.org, or follow us on Facebook and Twitter.
About Clinical and Translational Science Institute-Children's National:
The Clinical and Translational Science Institute at Children's National is a joint effort by Children's National Medical Center and The George Washington University Medical Center with several goals:
- To help researchers and physicians work together to develop new treatments for a variety of medical disorders
- To make it easier for new medical discoveries to move from the laboratory to the patients who need treatments
- To teach a new generation of medical professionals and scientists the importance of team science and collaborative approaches in pediatric diseases
For more information, visit www.ctsicn.org.
The project described is supported by Award Number UL1RR031988/UL1TR000075 from the NIH National Center for Advancing Translational Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.