Researchers at the George Washington University (GW) received a $3 million U01 grant from the National Institutes of Health to test the efficacy of a candidate recombinant hookworm vaccine, the next step in their goal to fight hookworm.
“Starting in mid-2015, we asked people in D.C. to volunteer to be infected with hookworm to help us establish a controlled human infection model,” said Jeffrey Bethony, Ph.D., professor of microbiology, immunology, and tropical medicine at the GW School of Medicine and Health Sciences. “We want our Phase I volunteers to know their efforts were not in vain and [were] critical to helping us take this next step, which is to test how effective the vaccine is against hookworm. We could not have done this without them.”
The next round of volunteers will receive the vaccine and then will be challenged with hookworm infection, to test the vaccine’s efficacy. The vaccine has been tested for safety and immunogenicity in several Phase I studies in the U.S., Brazil, and Gabon under an Investigational New Drug application with the U.S. Food & Drug Administration. Testing the vaccine in D.C., where people are not regularly infected with hookworm, will accelerate efforts to get the hookworm vaccine to people who need it most – the estimated 400-500 million people who are infected with hookworm, a parasite that can cause severe disability and anemia. After proving the efficacy of the vaccine in D.C., researchers will then seek volunteers in endemic areas in South America and Africa to test its efficacy in a less controlled environment.
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“The study will also test giving the vaccine along with different immunostimulants,” said David Diemert, M.D., associate professor of microbiology, immunology, and tropical medicine at the GW School of Medicine and Health Sciences and principal investigator of the trial. “Some volunteers will receive the immunostimulant, and some will not. This will help us see if a boost to the immune system will help the vaccine perform at a higher level.”
Hookworm is currently treated with yearly, widespread administration of anti-worm drugs, which does nothing to prevent re-infection and may create drug-resistance in the future. A vaccine would greatly improve the quality of life for those living with hookworm in endemic areas.
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