WASHINGTON, D.C.—November 5, 2012—The Sabin Vaccine Institute (Sabin) today announced the start of Part II of its Phase I clinical trial of the Na-GST-1 vaccine candidate, marking another major milestone in the progress toward developing a human hookworm vaccine. Part II of the trial commenced in Americaninhas, Brazil, following successful vaccinations in Part I of the study, which began in Belo Horizonte, Brazil in late 2011.
An independent Safety Monitoring Committee (SMC) recently reviewed results from Part I of the study and determined that no safety issues had been observed after vaccinating healthy adults who had never been exposed to hookworm. They concluded that these promising results were sufficient to allow researchers to proceed to the next stage of the trial, in which hookworm-exposed adults will receive the vaccine candidate.
Part II of the study is taking place in Americaninhas, a hookworm-endemic region of Brazil. The trial will enroll 66 healthy, hookworm-exposed adults between the ages of 18 and 45. Each volunteer will receive three injections over four months. Researchers will then follow each volunteer for 12 additional months, monitoring the vaccine's safety and analyzing the recipients' immune responses.
"Eventually, a human hookworm vaccine will be used to protect children at risk of infection. Because the hookworm-exposed population being vaccinated in Part II of this trial is representative of the eventual target population, we're closer to making this goal a reality," said Dr. David Diemert, the trial's principal investigator.
The trial is being conducted in partnership with a team based at the Oswaldo Cruz Foundation (FIOCRUZ) of the Brazilian Ministry of Health, a member of the Sabin Vaccine Institute Product Development Partnership (Sabin PDP).
"Moving forward with this trial helps advance the Sabin PDP's larger goal to develop safe, efficacious and low-cost vaccines for diseases of poverty," said Dr. Peter Hotez, president of the Sabin Vaccine Institute. "A human hookworm vaccine will help more than 600 million people worldwide who currently suffer from the infection."
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 intestinal blood loss leading to iron-deficiency anemia and protein malnutrition, which in turn can result in impaired physical and cognitive development in children.
The Sabin PDP began work on the human hookworm vaccine in 2000 with funding from the Bill & Melinda Gates Foundation and has additional support from the Dutch Ministry of Foreign Affairs, the Brazilian Ministry of Health, Texas Children's Hospital, the George Washington University, and the Children's National Clinical and Translational Science Institute. It 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 trials for the first-ever human hookworm vaccine candidate, 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 The Sabin Vaccine Institute Product Development Partnership (Sabin 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 University of Kansas Center for Research, Inc., the Oswaldo Cruz Foundation (FIOCRUZ) (Brazil), 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).