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news.The FDA has approved the Sabin Vaccine Institute's human hookworm vaccine for phase I safety trials, conferring investigational new drug status on the treatment candidate. Trials are expected to begin in the coming months.
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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.
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 over a year, that data and data from safety and tolerability trials in the US, will serve as required groundwork for a wider clinical trial, to ascertain the efficacy and safety of the new vaccine.