Sabin Vaccine Institute to Team with Brazilians on Human Hookworm Vaccine Trials
NEW CANAAN, CT, September 15, 2004—The Sabin Vaccine Institute, sponsor of research funded by the Bill & Melinda Gates Foundation on a newly developed vaccine to prevent human hookworm disease, has signed a memorandum of understanding with federal and state vaccine production facilities in Brazil for clinical development of the vaccine, including clinical trials and vaccine manufacture. Earlier this month, representatives from the Sabin Institute and The George Washington University (GW), where the research on the vaccine is underway, visited the research and production plants affiliated with the government of Brazil. The officials they met are hopeful that the new vaccine will prevent an ages-old disease endemic in Brazil that is caused by the devastating intestinal parasite.
Elated with the success of the trip, lead scientist Peter J. Hotez, MD, PhD, said, “This is the best and most substantive international collaboration I’ve ever had in 20 years of work in tropical medicine.” Hotez is professor and chair of the Department of Microbiology and Tropical Medicine at the GW Medical Center and senior fellow at the Sabin Institute, who has spent more than 20 years studying hookworm disease and devising a vaccine to prevent infection. His team met with Brazilian scientists at the Oswaldo Cruz Foundation, a research arm of the Brazilian Ministry of Health, and with researchers at the Butantan Institute, both of which operate vaccine-manufacturing plants. Officials from each group signed the memo of understanding.
According to Hotez, Brazil is like only a few countries in the world having both high endemic incidence of hookworm and pockets of extreme poverty, along with a high technology capacity and ability to develop biological products. “These features would also describe such middle income countries as China, Mexico, India and South Africa,” he said. “Brazil is one of the few countries with the technical capacity and intrinsic interest in the problem because hookworm is a public health threat in their nation.”
The trip was arranged in order to garner the support of the Brazilian government for their commitment to produce the hookworm vaccine, says Dean Mason, president of the Sabin Vaccine Institute, who along with Ciro de Quadros, MD, MPH, director of Sabin’s International Programs, and Maria Elena Bottazzi, PhD, project program manager and GW assistant professor of microbiology and tropical medicine, also made the trip.
“What is remarkable is the openness and cooperation of the government of Brazil at the highest levels,” said Mason, who signed the agreement on behalf of the Sabin Institute. “This is a country where they are willing to get the vaccine to the needy. The whole idea, if the vaccine field trials prove successful is to make the hookworm vaccine available for those afflicted and the poorest of the poor. No one is looking to make a commercial profit, but instead we are doing this for the best of reasons...necessity.”
The hookworm vaccine developed by Hotez will soon undergo clinical trials, so a team of a ozen workers led by project clinical director Jeffrey Bethony, PhD, is now assembling baseline data. The team is based in Belo Horizonte, Brazil, near the 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 www.sabin.org.