Breakthroughs Blog: Maternal health

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Sanofi Pasteur’s announcement that it will cease work on its Zika vaccine candidate has raised concerns about the future of Zika vaccine development. While the World Health Organization has reported 40 Zika vaccine candidates in development, with six candidates in phase 1 clinical trials, Sanofi was the only major pharmaceutical company working on a vaccine against the virus. Its exit from this space raises questions about who will fund clinical development if these candidates show further promise. Additionally, many unanswered questions remain about the virus’s epidemiology and the target population for a vaccine. While the number of Zika cases is now falling, Zika epidemics will likely reoccur in the future. Because of this risk, developing an effective and low-cost Zika vaccine must remain a priority. Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA) have formed a partnership to develop vaccines and drugs to protect against pandemic influenza. Among its projects, the partnership is seeking to develop a “universal” flu vaccine that protects against all or most influenza strains. This collaborative effort highlights a larger trend in partnerships between the private sector, the US government, and nonprofits to develop vaccines and technologies against emerging health threats for which there is currently limited commercial market. Pakistan has launched its first nationwide vaccination drive for polio, aiming to immunize over 37 million children. Pakistan is one of just three countries where polio cases remain, so this nationwide drive is an important step toward eradication. While polio still remains endemic in Pakistan, the number of cases has reduced dramatically in recent years from 306 cases in 2014 to just 4 today. Pakistan has experienced obstacles in its attempts to eradicate the virus, which include efforts by extremists to target immunization campaigns.

What do an onsite chlorine generator, fingerprint scanning technology for newborns, and temperature-monitoring wristband all have in common? The potential to save the lives of mothers and newborns in some of the poorest, hardest-to-reach communities around the world. These were among the many innovations pitched on July 27 at the DevelopmentXChange—the final stage of competition in the seventh annual Saving Lives at Birth: A Grand Challenge for Development, a prize program sponsored by the US Agency of International Development and other partners to identify and advance transformative, cost-effective solutions to improve maternal and newborn health, particularly during the first 48 hours after birth. Through the challenge, innovators compete for grants to develop, test, and bring their ideas to scale. This year, the challenge received more than 550 applications from across the world, with 53 teams chosen as finalists to compete at this year’s DevelopmentXChange. At the conclusion of the event, 15 winners were selected, with additional grant recipients to be announced later this year in the transition-to-scale category. GHTC members featured among finalists Among the 53 finalists were five promising innovations from GHTC member organizations, profiled below: Validation of an innovative, onsite, easy-to-use chlorine generator for infection prevention and control in labor wards* PATH The chlorine generator for infection prevention and control in labor wards. (Photo: GHTC/Marissa Chmiola)With just salt, water, and a power source, a hospital or clinic can create chlorinated water onsite to disinfect equipment and surfaces to keep mothers and babies healthy. That’s the idea behind the SE Flow Chlorinator—an easy-to-use, cost-effective chlorine generator designed for low-resource settings.  Infections are a leading cause of death for mothers and newborns during childbirth. While chlorine is one of the most widely-used and accepted methods for disinfecting surfaces, getting chlorine to remote health care facilities can be a challenge due to combination of weak supply chains, inconsistent transportation networks, and bureaucratic hurdles. The result: Close to one-third of facilities in low-income countries recently surveyed by the World Health Organization (WHO) did not have chlorine available. PATH and its partner MSR Global Health hope the SE flow will address chlorine supply chain hurdles by enabling facilities to produce consistently chlorinated water on the spot, at the quantity needed. The device also produces an additional benefit: cost savings. Over five years, the SE flow is estimated to save a facility 50 percent over the cost of purchasing chlorine on the market. PATH and MSR Global Health plan to test 50 of the devices next summary to collective evidence, refine the design, and support a broader roll out. Validation of an innovative newborn respiratory package of equipment and training* PATH Respiratory infections are a leading cause of infant mortality, particularly in premature infants whose lungs are not fully formed. Without strong lungs and appropriate oxygen intake, newborns face significant challenges in healthy development, including lifelong neurological damage or blindness. Continuous positive airway pressure (CPAP) therapy helps mitigate these challenges; however, the tools used in high-income nations to administer this therapy have traditionally been too costly to use in low-resource settings overseas.  A low-cost  bCPAP device for newborn health. (Photo: GHTC/Taylor Capizola) PATH and other partners developed a low-cost bubble CPAP (bCPAP) device, combined with an oxygen blender, that is appropriate for low-resource settings and has proven effective in controlling the flow of air to support breathing. To support further uptake and effective use of this intervention, PATH is now partnering with the Massachusetts General Hospital Division of Global Health and Human Rights to package the bCPAP, oxygen blender, nasal prongs, and a pulse oximeter with training and educational materials, including checklists, manuals, and wall charts. The training materials will be essential to expanding newborn access to respiratory therapy, particularly in facilities where no prior intervention existed and medical staff may be uncertain of how to best use these new tools. The team has also partnered with Sinapi biomedical, a South African biomedical manufacturer, to manufacture the package of tools and training materials to greatly expand the number of medical facilities using these interventions by bring the toolkit to scale. They expect that with Saving Lives at Birth support, mortality will drop 25 percent among newborns treated in facilities introducing bCPAP therapy for the first time. Building social accountability structures for respectful maternity care in Kenya: “RMC Virtual Space” Population Council Population Council's virtual space photos. (Photo: GHTC/Marissa Chmiola)The birth of a child can be one of the most moving experiences of a mother’s life, but in many low-income countries, it can also expose a woman to abuse and disrespect. Women who visit a health care facility during childbirth often face mistreatment, whether in the form of physical abuse, non-consent for physical examinations, neglect, or disrespectful comments. Often women are hesitant to report these incidents due to fear of reprisal or distrust that their feedback will be heard. Population Council has designed a low-cost mobile text message reporting platform that they believe will empower women to report their experiences and help providers comprehend the scope of the problem and develop solutions. This intervention works by enrolling women in the platform when they visit a facility for care. Following a visit, the patient is prompted through text message with a series of simple questions to collect information about her experience. The data is then aggregated and presented to the provider or facility in an easy-to-understand, dashboard-style system. Population Council chose to design the platform using text messaging as the basis for collecting feedback because it is ubiquitous across the African continent and provides a level of anonymity that encourages women to report their experience. The project team is at the concept stage and is currently testing the intervention in health facilities in Kenya to solicit feedback and refine its approach. Innovative packaging and pasteurization for donor human milk to improve health outcomes for preterm infants PATH Human milk banks play a critical role in ensuring that safe, high-quality human milk can be made available to infants whose mothers are unable to directly provide their own milk. Current guidelines for human milk pasteurization require temperature control of 62.5 degrees Celsius for 30 minutes to ensure all pathogens and bacteria are killed. Unfortunately, while this temperature kills microorganisms that can make infants sick, it also kills vital nutrients for an infant’s growth and development. No further international guidelines have been established, leaving engineers and scientists with the challenge of delivering safe, yet properly nutritious donor milk to milk banks. To solve this issue, PATH is seeking to improve the two processes involved in transporting human milk to milk banks: Pasteurization and packaging. PATH plans to research and narrow in on the optimal temperature range and timing capable of keeping human milk safe to drink and properly nutritious for infants. As part of this, PATH is also exploring the most effective packaging that help in achieving this temperature range and timing. Currently, the most common packaging for human milk is plastic or glass jars, but PATH researchers have found these jars do not transfer heat well or consistently. PATH plans to test a number of packaging options from stainless steel jars, which are commonly used in countries like India, to sterile plastic bags coated in aluminum—which in early testing have shown to distribute heat evenly and are easy to transport. Once the optimal temperature rage and optimal packaging are discovered, PATH plans to distribute this information widely to milk banks, donor human milk pasteurization equipment manufacturers, and human milk packagers to improve health and survival outcomes for all infants who receive heat-treated donor human milk globally. Advancing a simple, low-cost rapid diagnostic test for urinary adipsin: A promising new biomarker-based test for improving preclampsia screening in low-resource settings* PATH The preeclampsia (PE) test. (Photo: GHTC/Matt Robinson) Preeclampsia (PE) is a dangerous condition that causes organ failure and seizures, and it is one of the leading causes of maternal and newborn deaths worldwide. While diagnostic tests already exist that can provide early warning of risk factors, accurate tests require samples collected over 24 hours, and rapid tests were able to identify only 51 percent to 68 percent of risk cases. Thanks to a Saving Lives at Birth Round 4 Seed Award, PATH has developed an early prototype of a rapid diagnostic test (RDT) that is just as fast as existing RDTs, but is capable of catching 85 percent of risk cases early in the third trimester of pregnancy in plenty of time to take action. It is also temperature stable at 37 to 45 degrees Celsius and can be produced for pennies on the dollar of the cost of previous tests.  With its round seven award, the PATH team will undertake additional activities to bring the new RDT closer to broad scale use. First, the team will further optimize the test to expand its shelf life and determine the feasibility of increasing the test’s accuracy. Second, the team will explore whether the test—which currently requires a strip be dipped into urine in a separate container—can be incorporated into a form similar to at home pregnancy tests, making it easier to use and allowing women to take the test in the comfort of their own homes. Finally, the team will begin negotiations with commercial partners to scale up the product so it becomes widely available worldwide. The transformative power of innovation GHTC congratulates both our members and the other teams who were selected as finalists and award winners. This year’s prize winners will join the growing community of over 100 innovators supported by the Saving Lives at Birth partnership. Many of these innovations are beginning to have an impact as they are brought to scale. To date, the program has supported 1.5 million women and newborns and saved nearly 10,000 lives. The Saving Lives at Birth program proves that through creative partnerships and innovative ideas and interventions, we can create dramatic improvements in the health and well-being of people around the world. *indicates this intervention was among the 15 winners. GHTC staff including Taylor Capizola, program assistant; Matthew Robinson, MA, multilateral advocacy and policy officer; and Courtney Carson; US advocacy and policy officer, contributed to this article.  

Surgical masks are a popular accessory worn in public spaces during outbreaks of airborne diseases, however, in reality, they provide limited protection against pathogens; they may trap viruses, but they can’t kill them. Consequently, even just the act of removing the mask can expose the wearer to a virus. A team of scientists at University of Alberta are hoping to change that. They have adapted the standard surgical mask so that it can both trap and deactivate viruses. The inspiration for the mask came from a challenge faced by lead researcher Dr. Hyo-Jick Choi in his work adapting vaccines for oral administration: when liquids (i.e., vaccines) turn into solids (i.e., pills), they crystallize, damaging the viral components that make the vaccine effective. Dr. Choi realized he could turn this challenge into an advantage to target viruses that come in contact with surgical mask. He and his team developed and applied a safe, salt-based solution to the masks. As predicted, when a virus—in this case, influenza—came in contact with the mask, it was destroyed, as the droplet carrying it crystallized. Dr. Choi has received a provisional patent and plans to further advance the innovation. Advocates are calling for greater inclusion of pregnant women in clinical trials, a necessary step to address critical knowledge gaps and improve health care for pregnant women and their fetuses. In the United States, nearly two-thirds of women receive at least one prescription during pregnancy, yet more than 90 percent of drugs approved by the US Food and Drug Administration over the past three decades have not been proven safe for use in pregnancy. The hesitancy to include pregnant women in clinical trials is well-founded: drugs and vaccines can cross the placental barrier, resulting in complications or birth defects. However, pregnant women need safe, effective medicines, and clinical trials ensure that negative side effects are caught early, limiting the number of patients impacted. Further, pregnant women are more susceptible to certain pathogens, and as illustrated by the ongoing Zika outbreak, pathogens can cross the placental barrier too, making treatment during pregnancy all the more imperative. Additionally, women may process drugs at higher rates during pregnancy, consequently requiring higher doses. Advocates argue that while testing experimental drugs in pregnant women is risky, it is much safer than allowing a medicine to enter the market, leaving the decision to physicians and patients. The Defense Advanced Research Projects Agency (DARPA), an entity within the US Department of Defense, invests in high-risk, high-reward research, developing innovative technologies to advance US national security, with its health portfolio spanning research from neural and psychiatric health to infectious diseases. Through its Biological Technologies Office, DARPA scientists are taking an innovative approach to drug development. Rather than relying on chemicals to generate novel drug compounds, researchers are genetically modifying yeast, bacteria, and other microbes to do the job. Already, BARDA’s work with yeast has resulted in nearly 100 new molecules, and officials hope to reach 1,000 over the next three years. DARPA is also devising new platform technologies to expedite the development and improve the efficacy of vaccines against emerging infections. One method uses nucleic acids (i.e., RNA and DNA) to signal to the immune system how to respond to a pathogen, rather than introducing a pathogen and allowing the immune system to learn how to respond on its own. If successful, this technology could be adapted for different diseases and would provide instantaneous protection—a significant advantage as most vaccines take at least two weeks to provide protection.

It’s that time of year when Americans join together with family and friends and give thanks for the many things in life for which they are most grateful. In the spirit of the Thanksgiving holiday, GHTC asked our members and staff to share what they are most thankful for in global health. Here’s what they had to say: “I am thankful for all patients who take part in clinical trials so that the world will have more effective regimens to end TB, in all its forms.” Willo Brock, Senior Vice President of External Affairs, TB Alliance “I’m thankful there is increasing global interest in the development and production of vaccines for diseases of poverty, like hookworm, schistosomiasis, and Chagas.” Tara Bracken, Communications Associate, Sabin Vaccine Institute “I am thankful that 2016 was a turning point for women’s HIV prevention research—one that brought us hope for one day soon expanding women’s options with a long-acting vaginal ring. I am also grateful for the amazing partners who believe women’s health and empowerment matter!” Zeda Rosenberg, Founder and CEO, International Partnership for Microbicides “I’m thankful for the new generation of emerging R&D leaders who are both generating new knowledge and achieving global health impact.” Dr. Timothy Mastro, Chief Science Officer, FHI 360 “I’m thankful for sustained US government funding to fight emerging epidemics, like Ebola and Zika, through R&D and scientific advancement.” Lindsay Litwin, Jhpiego Innovations “I’m thankful that elimination of sleeping sickness is now a real possibility thanks to new tests being strategically implemented alongside new vector control technologies and improved treatment regimens.” Dr. Joseph Ndung’u, Head of Neglected Tropical Diseases Programme, FIND “I’m thankful that the six antimalarials MMV and partners have brought forward are saving young lives today!” Andrea Lucard, Executive Vice President of External Relations, Medicines for Malaria Venture “I’m thankful for research that has shown promise for an effective six-month regimen to cure XDR-TB [extensively drug-resistant TB].” Rabita Aziz, Policy Research Coordinator, ISDA Global Health “I’m thankful for the inspirational dedication and continued participation of all HIV vaccine clinical trial volunteers. Without you, the important work of finding a safe and effective HIV vaccine would not be possible.” Dr. Fran Priddy, Chief Medical Officer, International AIDS Vaccine Initiative “I’m thankful for the over 200 members of Congress who have co-sponsored the Reach Act to accelerate efforts to end preventable deaths of mothers and children around the world.” Brandon Ball, Policy and Advocacy Officer, PATH "I'm thankful for low-cost interventions like chlorhexidine gel for umbilical cord care being made more accessible to Sub-Saharan Africa to reduce newborn mortality." Assumpta Nantume, Communications Associate/Global Health Corps Fellow, Global Health Council “I'm thankful a new generation of Middle Eastern scientists are advancing the development, production, and characterization of new vaccines to help endemic countries better respond to the threat of infectious diseases like MERS, schistosomiasis, and leishmaniasis.” Chris Bennett, Senior Program Officer, Sabin Vaccine Institute “I’m thankful for pioneering donors such as UNITAID for funding development of new hepatitis C tests for countries where fewer than 1 percent of people living with hepatitis C have been diagnosed.” Catharina Boehme, Chief Executive Officer, FIND “I’m thankful for scientists and researchers who devote their lives to important global infectious disease work to help people around the world and to protect Americans here at home and the funding the US government provides for such important work.” Karen Goraleski, Executive Director, American Society for Tropical Medicine and Hygiene “I’m thankful for the tremendous progress we’ve made in advancing child and maternal survival and excited for the prospect of saving the lives of more than 6 million mothers and children by 2030 if we work together to advance and scale-up 11 promising innovations.” Heather Ignatius, Multilateral, US, and Europe Policy & Advocacy Team Lead, PATH “I’m thankful for researchers across the globe whose efforts have, with unprecedented speed, deepened our scientific understanding of and advanced new tools to prevent, detect, and treat Zika.” Kat Kelley, Senior Program Assistant, GHTC “I'm thankful so many good dengue vaccine candidates are in development that could help curb the growing global dengue epidemic.” Tara Bracken, Communications Associate, Sabin Vaccine Institute "I'm thankful for increased awareness on global antibiotic resistance and WHO's new evidence-based Infection Prevention and Control Guidelines." Danielle Heiberg, Advocacy Manager, Global Health Council “I'm thankful for the lives of mothers and babies that have been saved, sustained, and supported by midwives across the globe.” Shannon Egan, Jhpiego Innovations “I’m thankful that malaria rapid tests have contributed to better malaria control, which in turn has helped fuel a massive decline in childhood mortality over the past decade—and that partners around the world are working together to find innovative new solutions for identifying non-malarial causes of fever. Diagnosis matters!” Dr. Iveth J. González, Head of Malaria and Acute Febrile Syndrome programme, FIND “I’m thankful for the support of MMV’s committed donors and partners that make our work to develop new antimalarials for vulnerable populations possible.” Andrea Lucard, Executive Vice President of External Relations, Medicines for Malaria Venture “I’m thankful to be a part of the #StartStayAIDSFree initiative which aims to end AIDS in children by 2020.” Catherine Connor, Senior Director of Public Policy and Advocacy, Elizabeth Glaser Pediatric AIDS Foundation “I’m thankful that members of both major US political parties have continued to demonstrate strong, bipartisan support for global health research and development and US efforts to save lives around the world.” Marissa Chmiola, Communications Officer, GHTC