Phase 1 Clinical Trial of Human Hookworm Vaccine Successfully Completed
Important milestone advances world’s first and only human hookworm vaccine development initiative
WASHINGTON, D.C. — September 3, 2014 — The Sabin Vaccine Institute (Sabin) today announced that its product development partnership (Sabin PDP) successfully completed a Phase 1 clinical trial in Brazil of Na-GST-1/Alhydrogel®, a vaccine candidate for human hookworm, one of the most pervasive neglected tropical diseases (NTDs) affecting the world’s poor. 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.
The trial, which tested the safety and immunogenicity of the vaccine, ran from January 2011 to August 2014 and enrolled 102 healthy adults in Minas Gerais, Brazil. Final study results are expected in December 2014.
“It is promising that our hookworm vaccine candidate yielded positive safety and immunogenicity results in people living in such a high risk area,” said David Diemert, MD, principal investigator of the study, director of clinical trials of the Sabin PDP and associate professor at The George Washington University. “This encouraging outcome brings us one step closer to realizing sustainable control of hookworm. With more than 600 million people worldwide infected with this devastating disease, it is critical that we continue pursuing long-term, low-cost and safe protections for children and adults.”
Sabin PDP partners collaborating on this trial include The George Washington University; Centro de Pesquisas René Rachou, a regional unit of the Oswaldo Cruz Foundation (FIOCRUZ) of the Brazilian Ministry of Health; and Infectious Disease Research Institute (IDRI). Funding is provided by the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs.
Studies will continue to evaluate the Na-GST-1/Alhydrogel® vaccine in the United States through the Children’s National Clinical and Translational Science Institute and in Gabon through the HOOKVAC consortium. The Na-GST-1/Alhydrogel® vaccine is being tested in combination with the GLA-AF adjuvant that is produced by IDRI.
“Developing lasting solutions for hookworm and other NTDs trapping people in poverty requires comprehensive collaboration, cutting-edge science and leadership among health and policy leaders in endemic countries,” said Peter Hotez, MD, PhD, president of Sabin, 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. “The Sabin PDP is proud to pioneer developing and testing of the human hookworm vaccine and work with such esteemed global development partners in areas heavily impacted by NTDs, simultaneously accelerating progress and building up local capacity.”
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.
Sabin’s research and development of new vaccines is conducted through a collaboration called the Sabin Vaccine Institute Product Development Partnership (Sabin PDP), which works with leading private, academic and public institutions around the world to develop and test safe, effective and low-cost vaccines that benefit the world’s poorest communities. A complete overview of ongoing projects and partners is available at www.sabin.org/pdp