A new report notes that while vaccination has successfully brought under control many of the world’s most dreaded diseases, there are still a dismaying array of maladies causing human suffering to vast numbers of impoverished people around the globe for which no licensed (US or EU) vaccine exists. In a feature article posted August 22,, Vaccine Nation blogger Tim Peplow has selected ten such diseases that he thinks are especially important, and reports that the leader in vaccine development for four of the ten — human hookworm, schistosomiasis, Chagas disease, and leishmaniasis — is the Sabin Vaccine Institute’s Houston-based Product Development Partnership (PDP) program. The Sabin Vaccine Institute is a non-profit organization of scientists, researchers, and advocates dedicated to reducing needless human suffering caused by vaccine preventable and neglected tropical diseases. Sabin works with governments, leading public and private organizations, and academic institutions to provide solutions to tackle some of the world’s pervasive health challenges. Since its founding in 1993 in honor of pioneer oral polio vaccine developer, Dr. Albert B. Sabin, the Institute has been at the forefront of efforts to control, treat, and eliminate these diseases by developing new vaccines, advocating use of existing vaccines, and promoting increased access to affordable medical treatments. The Sabin Vaccine Institute Product Development Partnership (Sabin PDP) is based at Texas Children’s Hospital and Baylor College of Medicine’s National School of Tropical Medicine, is an internationally recognized PDP focused on creating safe, effective, low-cost vaccines for tropical infections in developing countries, and is focused on developing vaccines targeting preventable and neglected tropical diseases (NTDs). Together with many generous partners and donors, the Sabin PDP is leading the charge in developing these life-saving vaccines: Human hookworm Na-GST-1 (currently in Phase I trials in the U.S. and Brazil) and Na-APR-1 (Phase I trial to begin in the U.S. this year); schistosomiasis Sm-TSP-2, which is expected to enter U.S. clinical studies by the end of this year; and Chagas disease Tc24 and TSA-1, which is progressing through preclinical development.
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The Sabin PDP’s hookworm vaccine development project is the world’s first and only vaccine initiative targeting human hookworm infection, from which the Institute says more than 700 million people in the world are suffering today. Hookworms feed on blood and rob children of nutrients, and have even been shown to reduce childhood intelligence and cognition, with one result being reduction future wage earning capacity by 40% or more, therefore not only occurring in the setting of poverty, but they actually being an active agent in causing poverty. More than one-quarter of pregnant women in sub-Saharan Africa have hookworm and deliver profoundly anemic infants, hookworm being a leading contributor to maternal morbidity in Africa. The Sabin PDP’s human Hookworm vaccine development program was established in 2000 with funding from the Bill & Melinda Gates Foundation. According to Tim Peplow’s Vaccine Nation feature, hookworm disease is caused by an intestinal parasite that attaches itself to the intestinal wall, and while it can be symptom-free, if the hookworm is left untreated it can cause severe intestinal bleeding leading to iron-deficiency anaemia and protein malnutrition. He cites CDC data indicating that the soil-transmitted parasite is most commonly found in African, Asia and Latin America, and is estimated to affect up to 740 million people worldwide.
Schistosomiasis is caused by several species of parasitic worm, including Schistosoma haematobium and S. Mansoni, that are transmitted by snails. The former can cause bladder cancer and renal failure, while the latter can cause liver fibrosis and portal hypertension, according to the WHO cited by Mr. Peplow. The Sabin Institute estimates that Schistosomiasis afflicts over 200 million people around the globe and according to the Institute is the deadliest disease among the seven most prevalent NTDs, killing an estimated 280,000 people annually. The disease has a particularly horrific impact on girls and women, an example being that as many as 100 million girls and women in sub-Saharan Africa are afflicted with female genital schistosomiasis (FGS) a parasitic infection that produces bleeding ulcers on the cervix, uterus and lower genital tract, and also associated with a 3-4x increased risk of acquiring HIV/AIDS Thanks to private donations from Mr. Morton Hyman, Dr. Gary Michelson, Texas Children’s Hospital and the Blavatnik Family Foundation, the Schistosomiasis Vaccine Initiative (SVI) utilizes and leverages the Sabin Vaccine Institute PDP’s existing programmatic and technical infrastructure to produce and evaluate a schistosomiasis vaccine.
The Sabin PDP has initiated development for a new therapeutic vaccine for Chagas disease that will be undertaken with partners in Mexico, where between two and six million of the estimated 10 million people people globally are infected with this leading cause of poverty in Latin America. The disease is caused by the protozoan Trypanosoma cruzi, and the vector is the triatominae insect. Current efforts focus on the development of two vaccine candidate antigens that will ultimately comprise the first therapeutic vaccine for Chagas disease. The vaccine is being developed in partnership with Baylor College of Medicine, and Texas Children’s Hospital with support from the Slim Initiative for the Development of Neglected Tropical Disease Vaccines.
Leishmaniasis includes two major diseases, cutaneous leishmaniasis and visceral leishmaniasis, caused by more than 20 different leishmanial species. Cutaneous leishmaniasis, the most common form of the disease, causes skin ulcers, and is the form upon with the Sabin PDP focuses. Visceral leishmaniasis is more rare, but causes a severe systemic disease that is usually fatal without treatment. Leishmaniasis is transmitted by the bite of a sand fly, and the Institute says leishmanial species infect animals as well as humans, with distribution worldwide, but with 90% of visceral leishmaniasis cases occurring in India, Bangladesh, Nepal, Sudan, Ethiopia and Brazil, while 90% of cutaneous leishmaniasis cases occur in Afghanistan, Algeria, Iran, Saudi Arabia, Syria, Brazil, Colombia, Peru and Bolivia. As we reported here in June, Cutaneous leishmaniasis (CL) has been quickly spreading in Syria’s besieged ancient second city Aleppo, adding further to the civil war-torn misery there — the number of estimated cases ranging into the thousands or possibly even the hundreds of thousands with children and young people disproportionately affected. “It should come as no surprise that this disease would re-emerge with a vengeance as a result of a horrific civil war” and a breakdown in infrastructure and public health control measures,” Dr. Peter J. Hotez MD PhD, president of the Sabin Vaccine Institute wrote in a June 5, 2013, edition PLOS Blog posting entitled “‘Aleppo Evil’: The Ulcer, the Boil, the Sandfly, and the Conflict” “If fully realized,” says Sabin CEO Michael W. Marine, Ambassador (Ret), the Sabin PDP’s vaccines have the potential to dramatically improve the lives of the most marginalized people worldwide. The progress made in the past decade, in which increased access to vaccines has helped save millions of lives each year, serves as an important reminder of the purpose behind our innovative efforts. We are continually grateful for the generous support of our partners and donors, without whom our work would not be possible.” The Sabin PDP collaborates with partners from across the globe to develop new, low-cost vaccines that have essentially no commercial market for diseases that primarily impact the world’s poorest populations. With over a decade of experience, the program has produced a comprehensive, relatively low-cost model that serves as a blueprint for non-profit vaccine research and development and ongoing efforts to fight public health threats that adversely impact more than one billion people worldwide. On July 15, Sabin PDP announced the launch of a soil-transmitted helminth (STH) vaccine discovery program thanks to generous support from the Gary Karlin Michelson, M.D. Charitable Foundation, Inc. The Sabin PDP will endeavor to advance lead candidate antigens for ascariasis (roundworm) and trichuriasis (whipworm) infections and incorporate them into existing hookworm and schistosomiasis vaccines currently being developed by the Sabin PDP to create a vaccine against all four major human helminth infections. “I felt compelled to support efforts to develop a vaccine against the four most devastating parasitic worm infections because more than one billion innocent people, many of them small children, are unnecessarily plagued by these diseases,” explained Dr. Gary K. Michelson in a release. “I hope that rigorous research, studies and testing conducted by the Sabin PDP, along with additional investments, will eventually lead to meaningful discoveries.” Ascariasis, an infection of the small intestine, afflicts an estimated 800-900 million people and is a significant cause of acute intestinal obstruction in young children with high worm loads, leading to thousands of deaths annually. Trichuriasis, an infection of the large intestine, affects approximately 500 million people and is arguably the primary cause of inflammatory bowel disease in developing countries. These life-altering infections also significantly impede physical and cognitive growth in children. “We are excited to add this momentous program to the Sabin PDP’s existing portfolio of neglected tropical disease (NTD) vaccines,” says Dr. Peter Hotez. “This new initiative opens a potential way forward to alleviate the suffering of millions of people living in extreme poverty worldwide. A vaccine to prevent ascariasis and trichuriasis would be a significant public health advancement, particularly when co-formulated with hookworm and schistosomiasis antigens in a pan-anthelminthic vaccine.” This new vaccine project will leverage the Sabin PDP’s programmatic and technical infrastructure to carry out discovery, preclinical evaluation, and early feasibility studies of Ascaris and Trichuris candidate antigens. Ultimately, one or both antigens selected for development could be added to the hookworm and schistosomiasis vaccines already under development by the Sabin PDP. “We are deeply grateful for Dr. Michelson’s bold leadership and profound commitment to advancing essential scientific discovery work that will improve the lives of those most burdened by neglected tropical diseases,” adds Dr. Hotez, America’s leading advocate for and internationally recognized expert on tropical diseases and vaccine development. Along with serving as President and the most recognizable public face of the Sabin Vaccine Institute, Dr. Peter Hotez leads the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development and is founding Dean of the National School of Tropical Medicine at Baylor College of Medicine, Professor of Pediatrics and Molecular Virology & Microbiology and Chief of the Section of Pediatric Tropical Medicine at BCM, Endowed Chair of Tropical Pediatrics at Texas Children’s Hospital, and was recently named the Fellow in Disease and Poverty at Baker Institute for Public Policy at Rice University. He has served in membership or leadership roles with a multitude of professional organizations, including as a current member of the NIH Council of Councils Committee. He is a member of the Institute of Medicine of the National Academy of Sciences, and serves as immediate past President of the American Society of Tropical Medicine and Hygiene and Editor-in-Chief of PLoS Neglected Tropical Diseases. Dr. Hotez is also author of the book “Forgotten People, Forgotten Diseases: The Neglected Tropical Diseases and Their Impact on Global Health and Development” in which he describes how while neglected tropical diseases (NTDs) as being the most common infections of the world’s poor, few people in the developed West know about them and why they are so important. The entire vaccine development program of the Washington-based Sabin Vaccine Institute relocated to Houston in 2011 to establish the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development, located in the Ralph D. Feigin Research Center of Texas Children’s Hospital. This consolidation brought more scientists skilled in vaccine development to Sabin’s research programs, with representatives of BCM and Texas Children’s joining the Sabin Vaccine Institute’s Board. The collaboration represents a substantial expansion of efforts to develop and test vaccines for a range of diseases affecting low-income populations in the U.S. and worldwide, South Texas being one domestic center of focus. The relocation was also part of an agreement struck to recruit Dr. Hotez to the Texas Medical Center. On May 14, 2012 the executive committee of the Texas Medical Center’s board of directors voted to approve the membership of the Sabin Vaccine Institute, making it the 51st member institution of the world’s largest medical complex. Member institutions of the Texas Medical Center are all nonprofit organizations devoted to research, education, patient care and the prevention of disease and injury. Members participate in various Texas Medical Center councils and other activities to ensure collaboration and communication. As founding dean, Dr. Hotez accepted the first class of the National School of Tropical Medicine at Baylor College of Medicine in the fall of 2012 – concrete realization of a vision he says has had most of his professional life. “I’ve always been impressed with the London School of Hygiene and Tropical Medicine and the Liverpool School of Tropical Medicine,” Dr. Hotez commented in a BCM release. “There is no stand-alone school of tropical medicine in the United States – until now.” The Baylor school initially offers a diploma in tropical medicine to people in the health care field – physicians, nurses, public health experts, dentists, pharmacists, among others. On June 27 Dr. Hotez testified in a presentation, entitled “Addressing the Neglected Diseases Treatment Gap,” regarding Neglected Tropical Disease (NTD) R&D Funding before the United States House of Representatives Committee on Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights and International Organizations Hearing. In his presentation, Dr. Hotez explained to the lawmakers the importance of U.S. investments in neglected tropical diseases (NTDs), the work of Sabin and Baylor School of Tropical Medicine, and suggested ways the U.S. government could refine its strategy to more effectively help those who suffer most from these devastating diseases. Dr. Hotez’s academic research focuses on vaccine development for a wide range of neglected tropical diseases around the globe, as well as studies to increase awareness about the neglected tropical diseases in developing countries and in the United States. He notes the phenomenology of NTDs among the poor in wealthy countries, and new information from the U.S. census that 20 million Americans live in extreme poverty and a University of Michigan Center for Poverty finding that 1.46 million families with almost 3 million children live on less than $2 per day. “Although we call them neglected tropical diseases,” he noted “the truth is that poverty (more than climate) is the overwhelming determinant of these unique infections. At our National School of Tropical Medicine, we have turned the global health lens inward to find a previously hidden burden of NTDs among the poor in the U.S.” In addition to creating the Sabin Institute PDP, Dr. Hotez was instrumental in creating the Global Network for Neglected Tropical Diseases, an innovative partnership dedicated to controlling the spread of neglected tropical diseases (NTDs) in developing nations. He says he likes to call the NTDs “the most important diseases you have never heard of,” noting to the House subcommittee that “Today virtually every person on the planet who lives below the World Bank poverty figure – approximately 1.3 billion people, as well as most people who live on less than $2 per day suffers from one or more NTD.” “We’ve come a long way in terms of getting these diseases on the global health radar screen,” Dr. Hotez affirms. “Global health experts use the term ‘NTDs.’ (U.S. Secretary of State) Hilary Clinton has spoken about neglected tropical diseases, while both Presidents George W. Bush and Barack Obama have prioritized these conditions.” However, according to Global Network for Neglected Tropical Diseases, a Sabin Vaccine Institute initiative, funding for NTDs steadily increased to as much $89 million in FY12 – a $12 million increase from the previous year. But in FY13, President Barack Obama requested only $67 million as part of an effort to lower overall government spending. “With real success within sight,” says Dr. Hotez, any loss of momentum would be devastating.” Dr. Hotez contends that rapid and decisive global action is called for in order to prevent further spread and emergence of NTDs, and that further delays could have permanent and long-lasting destabilizing consequences. He advocates that the newly launched US State Department Office of Global Health Diplomacy should be mobilized in order to identify how the United States Government, possibly in partnership with research universities and institutes could provide important technical assistance for disease control and elimination. Photos Courtesy Sabin Vaccine Institute