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Kaslow D.C.,PATH | Biernaux S.,GSK Vaccines
Vaccine | Year: 2015

The Malaria Vaccine Technology Roadmap calls for a 2015 landmark goal of a first-generation malaria vaccine that has protective efficacy against severe disease and death, lasting longer than one year. This review focuses on product development efforts over the last five years of RTS, S, a pre-erythrocytic, recombinant subunit, adjuvanted, candidate malaria vaccine designed with this goal of a first-generation malaria vaccine in mind. RTS, S recently completed a successful pivotal Phase III safety, efficacy and immunogenicity study. Although vaccine efficacy was found to be modest, a substantial number of cases of clinical malaria were averted over a 3-4 years period, particularly in settings of significant disease burden. European regulators have subsequently adopted a positive opinion under the Article 58 procedure for an indication of active immunization of children aged 6 weeks up to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B. Further evaluations of the benefit, risk, feasibility and cost-effectiveness of RTS, S are now anticipated through policy and financing reviews at the global and national levels. © 2015.

News Article | November 10, 2016

Project led By University of Maryland School of Medicine will focus on accelerating the use of vaccines to protect from disease that kills more than 220,000 annually Baltimore, MD, November 10, 2016 - Typhoid fever, a bacterial infection that causes high fever and other disabling symptoms, remains a serious global problem in the developing world: it kills almost a quarter of a million people annually, and infects about 21 million. To help speed the introduction of, and access to, new and more effective typhoid vaccines, the University of Maryland School of Medicine (UM SOM) Center for Vaccine Development (CVD) has received a grant of $36.9 million from the Bill & Melinda Gates Foundation. The project, known as Typhoid Vaccine Acceleration Consortium (TyVAC), is a partnership with the Oxford Vaccine Group at the University of Oxford and PATH, an international nonprofit global health organization based in Seattle. TyVAC will focus on conjugate vaccines, which can trigger a stronger immune response in certain vulnerable populations, such as infants and children, than current typhoid vaccines. TyVAC will employ a multidisciplinary approach to study and control typhoid, and generate evidence that informs global policies. The project will work closely with governments and policymakers to introduce vaccines in lower-income countries with a high burden of typhoid. The effort will also examine how well the vaccine rollouts work in early adopter countries. The project's overall goal is to support accelerated, evidence-based decisions for new typhoid conjugate vaccine introductions that will significantly reduce the severe health and economic burdens of the disease. "Typhoid fever disproportionately impacts children and poor populations," said Kathleen Neuzil, MD, MPH, FIDSA, professor of medicine at UM SOM, director of CVD, and deputy director of the Institute for Global Health (IGH). "With our long history of work in typhoid and typhoid vaccines, we look forward to working with partners to catalyze action against this significant public health problem." "It is unconscionable that children are still dying by the thousands every year from diseases like typhoid that are completely preventable," said Anita Zaidi, director of the Enteric and Diarrheal Diseases team at the Bill & Melinda Gates Foundation. "The prevention and control of typhoid should be a global health priority and we are pleased to support the Typhoid Vaccine Acceleration Consortium as part of our overall strategy to combat typhoid through an integrated approach including access to clean water, improved sanitation, and immunization." At present, the currently available vaccines for typhoid fever are underutilized despite the substantial disease burden and a World Health Organization recommendation for the use of typhoid vaccines in areas of high burden. Typhoid conjugate vaccines have the promise to overcome some of the barriers of the currently available vaccines, providing a stronger immune response, a longer duration of protection, and the ability to be incorporated into the routine vaccination schedule targeted at children less than two years old. "We are excited to work in partnership with CVD to bring our expertise on typhoid infections and vaccines to the consortium and improve health through TyVAC," said Andrew Pollard, MD, PhD, professor of pediatric infection and immunity at the University of Oxford, and director of the Oxford Vaccine Group. Population density, limited sanitation, and poor water quality can provide a breeding ground for typhoid. "With increasing urbanization, we could see an even greater burden of typhoid," noted Deborah Atherly, PhD, head of Policy, Access, and Introduction for PATH's Center for Vaccine Innovation and Access. "Through TyVAC, we will work to ensure that typhoid vaccines finally reach those who need them most." "Typhoid is a significant public health problem in many parts of the world," said UM SOM Dean E. Albert Reece, MD, PhD, MBA, who is also vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor. "Over several decades, the CVD has helped save millions of lives. This generous grant from the Gates Foundation will allow our scientists, working with national and international partners, to continue with this crucial work." The CVD at the University of Maryland School of Medicine works nationally and internationally to prevent disease and save lives through the development and delivery of vaccines. As an academic research center, CVD is engaged in the full range of vaccinology, including basic science research, vaccine development, pre-clinical and clinical evaluation, and post-marketing field studies. Learn more at http://medschool. . The University of Maryland School of Medicine was chartered in 1807 and is the first public medical school in the United States and continues today as an innovative leader in accelerating innovation and discovery in medicine. The School of Medicine is the founding school of the University of Maryland and is an integral part of the 11-campus University System of Maryland. Located on the University of Maryland's Baltimore campus, the School of Medicine works closely with the University of Maryland Medical Center and Medical System to provide a research-intensive, academic and clinically based education. With 43 academic departments, centers and institutes and a faculty of more than 3,000 physicians and research scientists plus more than $400 million in extramural funding, the School is regarded as one of the leading biomedical research institutions in the U.S. with top-tier faculty and programs in cancer, brain science, surgery and transplantation, trauma and emergency medicine, vaccine development and human genomics, among other centers of excellence. The School is not only concerned with the health of the citizens of Maryland and the nation, but also has a global presence, with research and treatment facilities in more than 35 countries around the world. Learn more at http://medschool. . The University of Oxford is one of the top five higher education institutions in the world and hosts the Oxford Vaccine Group (OVG) in the Department of Paediatrics (http://www. ). OVG is a vaccine design, development, clinical trials, and laboratory evaluation research group with specific expertise in vaccine evaluation in paediatric populations. The University of Oxford has strategically made a major investment in infrastructure to support research on vaccines and immunity over the past two decades. The OVG is one of the largest academic research groups in the world focused on designing, developing, and evaluating vaccines for children, as well as characterizing immune response to vaccines and infectious diseases. PATH is the leader in global health innovation. An international nonprofit organization, we save lives and improve health, especially among women and children. We accelerate innovation across five platforms--vaccines, drugs, diagnostics, devices, and system and service innovations--that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health. Learn more at http://www.

Tate J.E.,Centers for Disease Control and Prevention | Burton A.H.,WHO | Boschi-Pinto C.,WHO | Steele A.D.,PATH | And 2 more authors.
The Lancet Infectious Diseases | Year: 2012

Background: WHO recommends routine use of rotavirus vaccines in all countries, particularly in those with high mortality attributable to diarrhoeal diseases. To establish the burden of life-threatening rotavirus disease before the introduction of a rotavirus vaccine, we aimed to update the estimated number of deaths worldwide in children younger than 5 years due to diarrhoea attributable to rotavirus infection. Methods: We used PubMed to identify studies of at least 100 children younger than 5 years who had been admitted to hospital with diarrhoea. Additionally, we required the studies to have a data collection midpoint of the year 2000 or later, to be done in full-year increments, and to assesses diarrhoea attributable to rotavirus with EIAs or polyacrylamide gel electrophoresis. We also included data from countries that participated in the WHO-coordinated Global Rotavirus Surveillance Network (consisting of participating member states during 2009) and that met study criteria. For countries that have introduced a rotavirus vaccine into their national immunisation programmes, we excluded data subsequent to the introduction. We classified studies into one of five groups on the basis of region and the level of child mortality in the country in which the study was done. For each group, to obtain estimates of rotavirus-associated mortality, we multiplied the random-effect mean rotavirus detection rate by the 2008 diarrhoea-related mortality figures for countries in that group. We derived the worldwide mortality estimate by summing our regional estimates. Findings: Worldwide in 2008, diarrhoea attributable to rotavirus infection resulted in 453 000 deaths (95% CI 420 000-494 000) in children younger than 5 years-37% of deaths attributable to diarrhoea and 5% of all deaths in children younger than 5 years. Five countries accounted for more than half of all deaths attributable to rotavirus infection: Democratic Republic of the Congo, Ethiopia, India, Nigeria, and Pakistan; India alone accounted for 22% of deaths (98 621 deaths). Interpretation: Introduction of effective and available rotavirus vaccines could substantially affect worldwide deaths attributable to diarrhoea. Our new estimates can be used to advocate for rotavirus vaccine introduction and to monitor the effect of vaccination on mortality once introduced. Funding: None. © 2012 Elsevier Ltd.

Mvundura M.,PATH | Tsu V.,Reproductive Health Global Program
International Journal of Gynecology and Obstetrics | Year: 2014

Objective To estimate the capital investment and recurrent costs of national cervical cancer screening and precancer treatment programs in 23 high-incidence countries in Sub-Saharan Africa in order to provide estimates of the investment required to tackle the burden of cervical cancer in this region. These 23 countries account for 64% of the annual cervical cancer deaths in this region. Methods Secondary data were used to estimate the financial costs of equipment purchases and economic costs of screening and treating eligible women over a 10-year period. Screening would be by visual inspection with acetic acid and treatment by cryotherapy or loop electrosurgical excision procedure. Results Approximately US $59 million would be required to purchase treatment equipment if cryotherapy were placed at every screening facility. Approximately 20 million women would be screened over 10 years. Cost per woman screened in a screen-and-treat program was either US $3.33 or US $7.31, and cost per woman treated was either US $38 or US $71 depending on the location of cryotherapy equipment. Conclusion It would take less than US $10 per woman screened to significantly decrease the cervical cancer deaths that will occur in Sub-Saharan Africa over the next 10 years. © 2014 International Federation of Gynecology and Obstetrics.

News Article | November 16, 2016

Seattle, November 16, 2016 --Self-injection of the contraceptive Sayana® Press is both feasible and highly acceptable among women participating in the first such research study conducted in sub-Saharan Africa, according to results published online by the journal Contraception. Sayana Press is an all-in-one injectable contraceptive that puts control of women's health in their hands. It is a subcutaneous formulation of the widely used injectable contraceptive depot medroxyprogesterone acetate (DMPA-SC) delivered in the PATH-developed Uniject™ injection system. "This pioneering research is important not only for the women of Uganda, but for all women," says Professor Dr. Anthony K. Mbonye, Acting Director General, Health Services, Ministry of Health, and co-investigator of the study. "The evidence that women can self-inject safely and successfully can help inform family planning program decision-making in countries around the world." In low- and middle-income regions of the world, nearly 225 million women want to plan their pregnancies but don't have access to a method that meets the reality of their lives. Expanding access to new contraceptive options such as Sayana Press can improve health and save lives by allowing women to delay or space their births. "Many women don't have the power to plan their families, because health centers are far away or partners refuse to support them to use contraceptives," explains Fiona Walugembe, PATH's Sayana Press coordinator in Uganda. "Self-injection gives women an additional option that increases both convenience and privacy." Sayana Press combines one dose of the contraceptive and a single-use needle in the Uniject device. Its streamlined design makes it small, light, and easy to use. It requires minimal training to use, making it especially suitable for community-based distribution--and for women to administer themselves through self-injection. Provider-administered Sayana Press is being offered as a family planning option in several countries around the world, including Uganda. Sayana Press is manufactured by Pfizer Inc. and Uniject is manufactured by BD. PATH first developed the Uniject injection system in the 1980s to make injections simpler and safer in low-resource settings. PATH and the Uganda Ministry of Health collected the newly published results to determine if Ugandan women liked the option and could inject themselves successfully, remember their reinjection dates, and safely store and dispose of the device--evidence critical for family planning decision-makers in low-income countries considering integration of self-injection in their programs. In the Uganda study, 380 women between the ages of 18 and 45 were trained by licensed nurses to self-inject Sayana Press, guided by a client instruction booklet. Those considered to be competent (98 percent) were given a Sayana Press device, instruction booklet, and reinjection calendar for self-injection at home three months later. Shortly after the participants' scheduled reinjection dates, nurses visited participants at home to learn whether they had reinjected on time and to observe their self-injection technique on a model. At this follow-up, 88 percent of participants demonstrated injection competence and 98 percent of those who self-injected expressed the desire to continue self-injecting. A similar study in Senegal was just completed. The studies build on previous self-injection research conducted in the United States and Europe. Self-injection of Sayana Press has been approved by the United Kingdom Medicines & Healthcare products Regulatory Agency and is under regulatory review in several other countries. While these approvals open the door for introduction of self-injection, further evidence is needed to guide family planning program decisions. Dr. Jane Cover, PATH Sayana Press Research Manager, puts the new Uganda study results in context: "Regulatory approval is necessary but not sufficient to make a new product or practice available to people in communities," she explains. "We have heard clearly from ministries of health in several African countries that they want more evidence on whether and how self-injection would work in their contexts. That evidence is starting to emerge with these first promising results from Uganda." Sayana Press injections are already widely available from family planning providers in many countries. For example, since 2014, nearly 500,000 doses of Sayana Press have been provided by health workers through country-led pilot introductions in Burkina Faso, Niger, Senegal, and Uganda, coordinated by PATH. These four countries are now moving forward with scale-up of provider-administered Sayana Press in their national family planning programs. Given the successful introduction of Sayana Press administered by community health workers and these promising self-injection research results, the Uganda Ministry of Health has begun offering Sayana Press self-injection as an option for women in Uganda's Mubende District--the first time the practice has been available in sub-Saharan Africa outside of a research setting. This month, PATH and the Mubende District Health Team trained approximately 100 health care providers at public-sector facilities to teach clients how to self-inject. The providers will offer Sayana Press as one family planning option, either by administering the injection or supporting clients to self-inject, according to their preference. The Uganda Ministry of Health and PATH hope to expand self-injection in the country in 2017. Sayana Press and Depo-Provera are registered trademarks of Pfizer Inc. Uniject is a trademark of BD. PATH is the leader in global health innovation. An international nonprofit organization, PATH saves lives and improves health, especially among women and children. PATH accelerates innovation across five platforms--vaccines, drugs, diagnostics, devices, and system and service innovations--that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. With these key partners, PATH delivers measurable results that disrupt the cycle of poor health. Learn more at http://www. .

Tsu V.D.,PATH | Jeronimo J.,PATH | Anderson B.O.,Fred Hutchinson Cancer Research Center
Bulletin of the World Health Organization | Year: 2013

The health concerns of women in their mid-adult years - when the prime age of reproduction has passed - have been traditionally given little or no attention by health systems and donors, despite the heavy burden that diseases such as breast and cervical cancer impose on women and their families. The risk of sexually transmitted infections that accompanies sexual relations and the risk of death and morbidity associated with pregnancy have long been recognized and have stimulated major control efforts that are finally yielding positive results. Much less attention has been focused, however, on how experiences in early life can affect women's health in adulthood. Breast and cervical cancers kill more women than any other types of cancer in all parts of the developing world. In most of Asia and Latin America and some African countries, deaths from these two forms of cancer now outnumber pregnancy-related deaths. There are five compelling reasons for focusing on these cancers now to try to reverse these epidemiologic trends: (i) the burden of breast and cervical cancer is large and is growing; (ii) effective screening and treatment are available; (iii) research is generating new knowledge; (iv) there are opportunities for synergy with other health programmes; and (v) noncommunicable diseases are the focus of much current interest.

Roberts T.J.,Stanford University | Carnahan E.,PATH | Gakidou E.,University of Washington
BMC Medicine | Year: 2013

Background: In 2010 more than 7.7 million children died before their fifth birthday. Over 98% of these deaths occurred in developing countries, and recent estimates have attributed hundreds of thousands of these deaths to suboptimal breastfeeding. Methods: This study estimated prevalence of suboptimal breastfeeding for 137 developing countries from 1990 to 2010. These estimates were compared against WHO infant feeding recommendations and combined with effect sizes from existing literature to estimate associated disease burden using a standard comparative risk assessment approach. These prevalence estimates were disaggregated by wealth quintile and linked with child mortality rates to assess how improved rates of breastfeeding may affect child health inequalities. Results: In 2010, the prevalence of exclusive breastfeeding ranged from 3.5% in Djibouti to 77.3% in Rwanda. The proportion of child Disability Adjusted Life Years (DALYs) attributable to suboptimal breastfeeding is 7.6% at the global level and as high as 20.2% in Swaziland. Suboptimal breastfeeding is a leading childhood risk factor in all developing countries and consistently ranks higher than water and sanitation. Within most countries, breastfeeding prevalence rates do not vary considerably across wealth quintiles. Conclusions: Breastfeeding is an effective child health intervention that does not require extensive health system infrastructure. Improvements in rates of exclusive and continued breastfeeding can contribute to the reduction of child mortality inequalities in developing countries. © 2013 Roberts et al.; licensee BioMed Central Ltd.

McAdams D.,PATH
Expert review of vaccines | Year: 2012

Research on spray drying as a processing method to improve vaccine stabilization and to enable novel routes of vaccine delivery has produced promising results; however, the method has yet to be adopted for the manufacture of vaccine products by the pharmaceutical industry. This article reviews the status of spray-drying technology and discusses barriers and opportunities for its future application to vaccines.

Despite improvements to water quality, sanitation, and the implementation of current prevention and treatment interventions, diarrhea remains a major cause of illness and death, especially among children less than five years of age in the developing world. Rotavirus vaccines have already begun making a real impact on diarrhea, but several more enteric vaccines will be necessary to achieve broader reductions of illness and death. Among the many causes of diarrheal disease, enterotoxigenic Escherichia coli (ETEC) and Shigella are the two most important bacterial pathogens for which there are no currently licensed vaccines. Vaccines against these two pathogens could greatly reduce the impact of disease caused by these infections. This review describes the approaches to ETEC and Shigella vaccines that are currently under development, including a range of both cellular and subunit approaches for each pathogen. In addition, the review discusses strategies for maximizing the potential benefit of these vaccines, which includes the feasibility of co-administration, consolidation, and combination of vaccine candidates, as well as issues related to effective administration of enteric vaccines to infants. Recent impact studies indicate that ETEC and Shigella vaccines could significantly benefit global public health. Either vaccine, particularly if they could be combined together or with another enteric vaccine, would be an extremely valuable tool for saving lives and promoting the health of infants and children in the developing world, as well as potentially providing protection to travelers and military personnel visiting endemic areas. © 2014 Elsevier Ltd.

This disclosure is directed to compositions that combine the polysaccharide-specific antibody protection afforded by the conventional vaccines through carrier effects provided by one or more pneumococcal common T-cell antigen(s) together with Streptococcus pneumoniae-specific Th-17 responses elicited by the pneumococcal carrier common T-cell antigen. The disclosed compositions are useful for pan-serotypic protection against NP carriage, and antibody responses against common pneumococcal virulence factors, potentially useful for pan-serotype protection against Streptococcus pneumoniae invasive diseases.

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