Sabin PDP Begins Phase 1 Clinical Trial to Co-Administer Two Novel Hookworm Vaccine Candidates in Brazil
WASHINGTON, D.C. — April 29, 2016 — The Sabin Vaccine Institute (Sabin) today announced that its Product Development Partnership (Sabin PDP) began a Phase 1 clinical trial of Na-APR-1 (M74)/Alhydrogel® co-administered with Na-GST-1/Alhydrogel in Brazilian adults. The trial will evaluate the safety and immune response of co-administering these novel vaccine candidates in 60 healthy adults living in a hookworm-endemic area.
The George Washington University (GWU) in partnership with the Oswaldo Cruz Foundation (Fiocruz) of the Brazilian Ministry of Health is conducting the study in Americaninhas, Minas Gerais, Brazil. The study began in January and is expected to run through March 2017. Volunteers will be injected with one or both vaccine products, to determine if administering both at the same time produces an improved immune response over giving each of them separately.
“With this trial, we hope to build on the work of our previous studies in Brazil to develop a safe, effective and affordable vaccine to prevent human hookworm infection,” said David Diemert, MD, director of clinical trials of the Sabin PDP and associate professor at GWU in Washington, DC. “A vaccine, in combination with currently available drugs, could help turn the tide against this pervasive disease, which afflicts the world’s poorest communities.”
Human hookworm infection, one of the most common neglected tropical diseases (NTDs), is typically treated through annual mass drug administration of deworming pills — most commonly, albendazole or mebendazole. However, despite generous drug donations from pharmaceutical companies, treatment alone is not enough to edge out hookworm infection in highly endemic areas.
Sabin previously sponsored a Phase 1 clinical trial of its Na-GST-1 vaccine, led by the same Fiocruz team in Brazil. The trial ran from January 2011 until August 2014, enrolled 102 healthy adults, and demonstrated that the vaccine is safe and immunogenic in this population. The current clinical trial co-administers Na-GST-1 with Na-APR-1 (M74)/Alhydrogel to determine if it will result in a higher levels of protection than either vaccine alone.
“NTDs produce a level of global disability and suffering equivalent to better-known infections such as HIV/AIDS and malaria,” said Peter Hotez, MD, PhD, president of Sabin, director of the Sabin Vaccine Institute PDP and dean of the National School of Tropical Medicine at Baylor College of Medicine. “Despite their global public health importance, disparities in the development of vaccines for NTDs have occurred due to their low prioritization and the lack of substantive research and development programs for NTD vaccines. The Sabin PDP is working to fill this gap and reduce the global burden of hookworm and other NTDs.”
Hookworm is an intestinal parasite most commonly found in tropical and subtropical climates, particularly in Africa and Latin America. Hookworms infect approximately 440 million people worldwide. It is one of three members of a family of parasites known as the soil-transmitted helminths. Left untreated, hookworm can cause intestinal blood loss leading to iron-deficiency anemia and protein malnutrition, particularly in pregnant women and children. Chronic hookworm infection in children contributes to physical and intellectual impairment, learning difficulties and poor school performance.
The Sabin PDP is based at Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine in Houston, Texas. Other collaborators include the University of California San Francisco and Johns Hopkins University. The Infectious Disease Research Institute, based in Seattle, manufactured the GLA-AF adjuvant that will be used in the trial. Funding for this study is provided by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (grant #1 U01 AI116414-01).
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.