FDA Approves Human Hookworm Vaccine for Phase I Safety Trials

Clinical trials to test the safety of a first-of-its-kind human hookworm vaccine will begin in the Washington, DC area in a couple of months after the U.S. Food and Drug Administration conferred investigational new drug status on the vaccine. No current vaccine is available to prevent hookworm disease, which is one of the most common chronic infections of humans with an estimated 740 million cases in areas of rural poverty in the tropics and subtropics.

The Human Hookworm Vaccine Initiative is sponsored by the Albert B. Sabin Vaccine Institute, and is funded by the Bill & Melinda Gates Foundation. The research is conducted at The George Washington University Medical Center. Peter J. Hotez, MD, PhD, professor and chair of GW's Department of Microbiology and Tropical Medicine leads the scientific team and has been responsible for the development of the vaccine. "Approval to begin safety trials is a major milestone for the human hookworm vaccine project," Hotez said. "It has taken an amazing amount of our team's effort to get us to the current stage of vaccine development. Of course, our ultimate goal is to take this research to developing countries where the vaccine will be tested in individuals who suffer from hookworm infection."

Human hookworm infection is caused by parasitic worms that fasten onto the inner layers of the small intestine using their teeth-like projections and cause blood loss at the attachment site. Hookworm disease refers to the iron deficiency anemia that results from moderate and heavy infections. Because women and young children have the lowest iron stores, they are the most vulnerable to chronic hookworm blood loss. In children, chronic hookworm disease contributes to physical growth retardation and cognitive impairment. Hookworm is considered a major health threat to adolescent girls, women of reproductive age, and to outcomes in pregnancy and is a major contributor to misery and suffering in the poorest of the poor.

This first phase of clinical research will assess the initial safety of the new hookworm vaccine, as well as the immune system's response to vaccination. Several more years of subsequent research on the vaccine's effect will be required before it can be licensed for use. Looking towards the future, the Sabin Vaccine Institute signed a memorandum of understanding this past fall with federal and state vaccine production facilities in Brazil for clinical development of the vaccine. A Human Hookworm Vaccine Initiative team based in Brazil is now assembling baseline data in a rural area impacted by hookworm disease. In just more than a year, that data and data from safety and tolerability trials in the United States, will serve as required groundwork for a wider clinical trial, to ascertain the efficacy and safety of the new vaccine.

The Human Hookworm Vaccine Initiative of the Sabin Vaccine Institute and the Bill & Melinda Gates Foundation is being conducted at The George Washington University Medical Center.

For more information, visit http://www.sabin.org/.